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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 3/29/18-3/30/18

Meeting Details:

On March 29, 2018, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application to market a novel continuous glucose monitoring (CGM) device system, the Senseonics, Inc. Eversense CGM System. This device requires minor surgery to implant and remove, and if approved, would provide 90 days of sensor glucose values from each implanted sensor. The Eversense CGM System measures patients’ glucose concentrations from subcutaneous interstitial fluid similar to approved CGM systems. All CGM devices currently or previously marketed used electrochemistry to measure glucose in interstitial fluids, last for 3 to 11 days and are inserted via a small-gauge needle by the end user. The proposed CGM system uses a fluorescence-based measurement technique, requires minor surgery for subcutaneous implantation, and will have a 90-day sensor wear period. The proposed CGM sensor also includes a drug component (dexamethasone acetate) intended to mitigate negative effects on sensor accuracy and sensor life from the foreign body response at the sensor insertion site. The proposed intended use, as stated by the sponsor, is as follows: The Eversense CGM System continually measures glucose levels in adults (age 18 and older) with diabetes for the operating life of the sensor. The system is intended to: • Aid in the management of diabetes. • Provide real-time glucose readings. • Provide glucose trend information. • Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. On March 30, 2018, the committee will discuss and make recommendations regarding measuring blood glucose using capillary blood with blood glucose meters in all hospital patients, including those receiving intensive medical intervention/therapy and patients with decreased peripheral blood flow, such as with severe hypotension, shock, hyperosmolar-hyperglycemia and severe dehydration (e.g., patients in intensive care settings). Currently, FDA has cleared one glucose meter for use all over the hospital using venous and arterial blood. FDA understands that being able to make capillary blood measurements in all hospitalized patients using FDA cleared and Clinical Laboratory Improvement Amendments (CLIA) waived (i.e., designated as waived per the standards in the CLIA) glucose meters would be more convenient and timely for hospital staff. FDA would like to present new data from capillary blood measurements on glucose meters in patients receiving intensive medical intervention/therapy to the Clinical Chemistry and Clinical Toxicology Devices Panel. FDA would like to receive feedback from the advisory panel on the benefits and risks of measuring capillary blood using blood glucose meters in this intended use population, and the considerations for CLIA waiver for this use.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 8/10/16-8/10/16

Meeting Details:

On August 10, 2016, the committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc. The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel of the MDAC

Meeting Date: 7/21/16-7/22/16

Meeting Details:

On July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.’s, Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.
On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere Afinion™ HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS. The proposed intended use, as stated by the sponsor: Alere Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. For use in clinical laboratories and point of care laboratory settings.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory

Meeting Date: 4/25/13-4/25/13

Meeting Details:

On April 25, 2013, during session I, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Methotrexate,” Product Code LAO, as unclassified under the 510(k) premarket notification authority. Methotrexate enzyme immunoassays are for the quantitative determination of methotrexate. The measurements obtained are used in monitoring levels of methotrexate to ensure appropriate drug therapy. FDA is seeking panel input on the safety and effectiveness of methotrexate enzyme immunoassays. On April 25, 2013, during session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Phencyclidine,” Product Code LCM, and “Radioimmunoassay, Phencyclidine,” Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays. 3 On April 25, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel

Meeting Date: 10/29/01-10/29/01

Meeting Details:

The committee will provide advice and recommendations on the types of data and/or labeling needed in premarket notification (510(k)) submissions for glucose test systems to address problems associated with using blood samples from alternate sites, such as the forearm, upper arm, thigh, calf, or base of the thumb.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Panel

Meeting Date: 9/24/01-9/24/01

Meeting Details:

The committee will provide advice and recommendations on the types of data and/or labeling needed in premarket notification (510(k)) submissions for glucose test systems to address problems associated with using blood samples from alternate sites, such as the forearm, upper arm, thigh, calf, or base of the thumb.

 

       
Location: Gaithersburg Hilton Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel

Meeting Date: 11/13/00-11/14/00

Meeting Details:

On November 13, 2000, the committee will discuss two draft guidances: "Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications" and "Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications." The prescription use guidance supersedes the document entitled "Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies." The OTC use guidance supersedes the document entitled "Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to be used by the Consumer." ------------------------------------------------->On November 14, 2000, the committee will discuss and make recommendations on a premarket notification (510(k)) for a first-of-a-kind prescription use screening device for heroin in human hair.

 

       
Location: Gaithersburg Hilton Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices

Meeting Date: 3/24/00-3/24/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a peptide test indicated as an aid in the diagnosis of congestive heart failure. The device is a product of the Biosite Corporation.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices

Meeting Date: 12/6/99-12/7/99

Meeting Details:

On December 6, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application for a device indicated for frequent, automatic and non-invasive monitoring of glucose levels in adults with diabetes. On December 7, 1999, the committee will discuss and make recommendations on general issues regarding over-the-counter devices for measurement of vaginal pH. The discussion will include appropriate claims, study designs to support claims, performance expectations, and labeling.

 

       
Location: Marriott Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices

Meeting Date: 10/28/99-10/28/99

Meeting Details:

The committee will discuss and make recommendations on a premarket notification for an over-the-counter device that measures triglycerides from whole blood fingersticks.

 

       
Location: Corporate Blvd. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices

Meeting Date: 2/26/99-2/26/99

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for a continuous glucose monitoring system that is indicated for the continuous recording of interstitial glucose levels in persons with diabetes mellitus.

 

       
Location: Marriott Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

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

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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 OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 6/6/19-6/6/19

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Meeting Details:

The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment- intolerant or non-responsive multidrug-resistant tuberculosis (TB).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint DSRM and Anesthetic and Analgesic AdComm

Meeting Date: 6/11/19-6/12/19

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Meeting Details:

FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients. FDA frequently hears from patients and healthcare providers that higher dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. There is a strong association between higher opioid dose and duration/persistence of opioid analgesic therapy and assessing temporal relationships and independent effects of opioid dose and duration on the risks of both addiction and overdose is challenging. In addition, FDA acknowledges the complex and evolving landscape of the opioid epidemic, with myriad Federal, State, local, and payer efforts to encourage more judicious prescribing of opioid analgesics, and the growing threat of highly lethal illicit opioids. To better understand both the clinical utility and harms of higher dose opioid analgesics in the current environment, and to discuss the advantages and disadvantages of various potential risk management strategies, FDA brings these issues to an advisory committee to seek input and advice from the clinical, patient, public health, and research communities. In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.

 

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

Meeting Date: 6/19/19-6/20/19

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Meeting Details:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of ODAC

Meeting Date: 6/20/19-6/20/19

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Meeting Details:

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website: https://www.fda.gov/?AboutFDA/?CentersOffices/?OfficeofMedicalProductsandTobacco/?OCE/?ucm544641.htm. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors. During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/14/19-5/14/19

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 211810 for pexidartinib capsule, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, also referred to as giant cell tumor of the tendon sheath or pigmented villonodular synovitis, which is associated with severe orbidity or functional limitations, and which is not amenable to improvement with surgery. During the afternoon session, the committee will discuss NDA 212166 for quizartinib tablets, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory acute myeloid leukemia, which is FLT3-ITD positive, as detected by an FDA-approved test.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/8/19-5/8/19

Meeting Details:

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 5/7/19-5/7/19

Meeting Details:

The committee will discuss the following topics: (1) Approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of `exposure-matching' under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of `exposure matching,' including the necessary assumptions and any limitations.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 4/25/19-4/26/19

Meeting Details:

Day 1 - On April 25th, The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. Day 2 - On April 26th, The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Past Meetings

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