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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/30/19-5/31/19

Meeting Details:

On May 30, 2019, the committee will discuss and make recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls). On May 31, 2019, the committee will discuss and make recommendations regarding the reclassification of certain absorbable hemostatic agents from Class III to Class II (special controls).

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/19-3/26/19

Meeting Details:

On March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 9/20/16-9/21/16

Meeting Details:

On September 20 and 21, 2016, the Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, "Dressing, Wound, Drug," and are considered "pre-amendments" because they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. As a part of the classification process, FDA is seeking committee input on the indications for use, risks to health, and safety and effectiveness of these wound care products, and how they should be classified. They may be classified in class I (general controls), class II (special and general controls), or class III (premarket approval (PMA), requiring demonstration of safety and effectiveness for each product). FDA believes some of these products may meet the definition of class II whereas others may meet the definition of class III in light of their intended use, composition, the extent of evidence of clinical benefit, and the risks they pose. For the subset of the these products that contain antibiotics, FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/27/15-2/27/15

Meeting Details:

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows: The Radiesse device is for hand augmentation to correct volume deficit in the hands. FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/26/13-6/26/13

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/2/13-5/2/13

Meeting Details:

On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juv[eacute]derm Voluma XC sponsored by Allergan, Inc. Juv[eacute]derm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juv[eacute]derm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/ supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/21/12-6/21/12

Meeting Details:

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the Medical Devices

Meeting Date: 12/1/11-12/1/11

Meeting Details:

On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in mid-to-deep subdermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/30/11-8/31/11

Meeting Details:

On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 4/27/11-4/27/11

Meeting Details:

On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/10-11/18/10

Meeting Details:

On November 18, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for MelaFind, sponsored by MELA Sciences. MelaFind(R) is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ``ugly duckling'') cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.

 

       
Location: Holiday Inn College Park College Park, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/10-3/25/10

Meeting Details:

On March 25, 2010, the committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer (both melanoma and non-melanoma). The committee will be asked to recommend whether changes to current classification or current regulatory controls of UV emitting devices (lamps) used for tanning are needed.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/08-11/19/08

Meeting Details:

On November 18, 2008, the committee will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers. In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses. On November 19, 2008, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will make recommendations on how to quantify the effects of devices with various types of energy sources, such as light-based products, light-based combination devices, ultrasound devices (including focused ultrasound devices), massagers combined with other energy modalities, cryogenic energy devices, radiofrequency ablation devices, and microwave systems, on dermatologic conditions.

 

       
Location: Rio Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/24/06-8/25/06

Meeting Details:

On August 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: cyanoacrylate tissue adhesive.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/25/05-8/26/05

Meeting Details:

On August 25, 2005, the committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsInamed & Mentor - General & Plastic Surgery

Meeting Date: 4/11/05-4/13/05

Meeting Details:

On April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Related Link From Inamed. Also Mentor will be presenting: Related Link From Yahoo

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/12/04-5/12/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an in situ polymerizable sealant material intended to be used to seal air leaks following pulmonary surgery.

 

       
Location: Holiday Inn, GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/04-3/25/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients.

 

       
Location: Hilton Washington Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/21/03-11/21/03

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications (PMAs) for injectable devices intended to restore soft tissue facial contours such as nasolabial folds.

 

       
Location: HOL Gaithersburg , MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 10/14/03-10/15/03

Meeting Details:

On October 14 and 15, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for Silicone Gel-Filled Breast Prostheses.

 

       
Location: Marriott Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-10:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/24/03-7/24/03

Meeting Details:

The committee will discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. There will also be a discussion of a general issue: clinical trial issues for devices designed for percutaneous removal of breast tumors.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/28/03-2/28/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an injectable wrinkle treatment device. There will also be a discussion of two general issues: (1) clinical trial issues for devices designed for ablation of pulmonary tumors, and 2) clinical trial issues for devices designed for the treatment of emphysema.

 

       
Location: Hilton Gaithersburg , MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/8/02-7/9/02

Meeting Details:

On July 8, 2002, the committee will discuss and make recommendations on the classification of a preamendment device, the silicone elastomer for scar management. The committee will also discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. On July 9, 2002, the FDA and two manufacturers of approved saline inflatable breast implant devices will present postmarket information to the committee for their consideration.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/17/01-7/17/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Interactive Wound and Burn Dressing.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 5/8/00-5/8/00

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications: 1) for an in situ polymerizable surgical mesh intended to be used to seal air leaks following thoracic cavity surgery; and 2) for an interactive wound and burn dressing intended to be used for the treatment of diabetic foot ulcers by FocalSeal.

 

       
Location: Gaithersburg Marriott Washingtonian Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 3/1/00-3/3/00

Meeting Details:

On March 1, 2000, there will be a brief FDA presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997. Also on March 1, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for Saline Inflatable Breast Prostheses. On March 2, 2000, the committee will discuss, make recommendations and vote on two PMAs for Saline Inflatable Breast Prostheses. On March 3, 2000, the committee will discuss content, format, and consistency issues involving the labeling information provided to patients considering saline-filled breast prostheses.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 1/12/00-1/12/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Absorbable Adhesion Barrier Device.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 8/2/99-8/2/99

Meeting Details:

The committee will discuss possible revisions to the 1995 draft guidance

 

       
Location: Corporate Bldg., conference room 020B, 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 6/16/99-6/16/99

Meeting Details:

On June 16, 1999, the committee will discuss, make recommendations and vote on premarket approval application for computer-guided surgical instruments for use in endoscopic surgery. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Gaithersburg Hilton, Salons C, D, and E, 620 Perry Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 11/17/98-11/17/98

Meeting Details:

The committee will discuss and make recommendations on a proposal for the classification of preamendment wound dressing medical devices based on: 1) a proposed rule published in the Federal Register of September 19, 1989 (54 FR 38600); 2) comments received in response to the proposed rule; and 3)comments from the General and Plastic Surgery Devices Panel Meeting of July 20, 1995. The committee will also discuss and make recommendations on the reclassification of preamendment class III topical oxygen devices for woundhealing on extremities based on information received from a call for safety and effectiveness information under section 515(I) published in the Federal Registers of August 14, 1995 and June 13, 1997 (60 FR 41986 and 62 FR 32355, respectively).

 

       
Location: FDA Corporate Blvd., Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/10/19-12/10/19

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 022034, for vernakalant HCl solution, for intravenous injection, submitted by Correvio International Sàrl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: Atrial fibrillation = 7 days duration, and for post-cardiac surgery patients: Atrial fibrillation = 3 days duration.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Amarin Pharma Inc.

Meeting Date: 11/14/19-11/14/19

Meeting Details:

The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/13/19-11/14/19

Meeting Details:

On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Boehringer Ingelheim

Meeting Date: 11/13/19-11/13/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: As an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/8/19-11/8/19

Meeting Details:

On November 8, 2019, the Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on the development of chikungunya vaccines.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 11/6/19-11/7/19

Meeting Details:

On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.

 

       
Location: Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic AdComm
Sponsor: Agile Therapeutics, Inc.

Meeting Date: 10/30/19-10/30/19

Meeting Details:

The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm
Sponsor: AMAG Pharmaceuticals

Meeting Date: 10/29/19-10/29/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA 021945/S-023#) for MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter) manufactured by AMAG Pharmaceuticals. In 2011, MAKENA received approval under the accelerated approval pathway (21 CFR part 314, subpart H, and section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. MAKENA was shown in the preapproval clinical trial to reduce the proportion of women who delivered at less than 37 weeks gestation, a surrogate endpoint that FDA determined was reasonably likely to predict a clinical benefit of preterm birth prevention, such as improved neonatal mortality and morbidity. As required under 21 CFR 314.510, the Applicant conducted a postapproval confirmatory clinical trial to verify and describe clinical benefit. AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity. The committee will consider the trial's findings and the sNDA in the context of AMAG Pharmaceuticals' confirmatory study obligation.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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