Meeting Details:

On October 2, 2020, 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 selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.

Meeting Details:

On October 7, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TransMedics Organ Care System (OCS)--Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics OCS--Heart, as stated in the PMA, is as follows: The TransMedics OCS Heart System is a portable ex-vivo organ perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts with one or more of the following characteristics for transplantation into a potential recipient in a near-physiologic, normothermic, and beating state: Expected cross-clamp or ischemic time = 4 hours due to donor or recipient characteristics (e.g., donor-recipient geographical distance, expected recipient surgical time) Donor Age = 55 years Donors with history cardiac arrest and downtime = 20 minutes Donor history of alcohol use Donor LV Ejection Fraction = 50 percent but = 40 percent Donor history of Left Ventricular Hypertrophy (septal or posterior wall thickness of >12 and = 16 millimeters).

Meeting Details:

The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder. The product has been formulated with properties intended to deter non-oral abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, including the potential public health impact, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 213378, olanzapine and samidorphan oral tablets, submitted by Alkermes, Inc., for the proposed indications of schizophrenia and bipolar disorder. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 213378, olanzapine and samidorphan oral tablets, submitted by Alkermes, Inc., for the proposed indications of schizophrenia and bipolar disorder.

Meeting Details:

On October 22, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

Meeting Details:

On October 22, 2020, the committee will discuss and make recommendations on the topic “Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices.” Specifically, we will discuss the composition of the datasets on which the software “learns”, components of the device information shared with patients, and factors that impact patient trust in the technology. Large clinical datasets are used to train and improve AI/ML algorithms, allowing transformational improvements in the diagnosis, clinical decision making, and treatment of patients. Devices using AI/ML technology will transform healthcare delivery by increasing efficiency of key processes in the treatment of patients. Health products powered by AI/ML are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots to algorithms for detecting cancer in mammography and interpretations of chest X rays. Despite the rapid advancement and integration, AI/ML systems may have algorithmic biases, limited generalizability, and lack transparency in their assumptions based on potential limitations of training datasets. The recommendations provided by the committee will address the importance of including various demographic groups in AI/ML algorithm development. The recommendations will also address the impact of the user interface and transparency including what information and how the information about the devices could be communicated to foster patient trust in the AI/ML devices.

Meeting Details:

On October 27, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Neovasc Reducer System sponsored by Neovasc, Inc. The proposed Indication for Use of the Neovasc Reducer System is for patients suffering from refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

Meeting Details:

On September 15, 2020, the Pediatric Advisory Committee (PAC) will meet to discuss the pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155). The PAC will meet to discuss the following products listed by FDA Center: Center for Biologics Evaluation and Research a. GAMUNEX-C (immune globulin intravenous (human)), 10%, Caprylate/Chromatography Purified Center for Devices and Radiological Health a. FLOURISH Pediatric Esophageal Atresia Device (humanitarian device exemption) Center for Drug Evaluation and Research a. ADZENYS ER (amphetamine) extended-release oral suspension b. MYDAYIS (mixed salts of a single-entity amphetamine product) extended-release capsule, for oral use c. ORENCIA (abatacept) for injection, for intravenous use d. VYVANSE® (lisdexamfetamine dimesylate) capsule and chewable tablet FDA will discuss acute dystonia associated with the use of attention deficit hyperactivity disorder (ADHD) medications (including methylphenidate products, amphetamine products, and atomoxetine). Additionally, FDA will discuss acute hyperkinetic movement disorder associated with the combined use of ADHD stimulants and antipsychotics (including first-generation antipsychotics and second-generation antipsychotics). The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will discuss the results of required postmarketing studies (Postmarketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4) that evaluated the effect of the reformulation of OXYCONTIN (oxycodone hydrochloride extended-release tablets, manufactured by Purdue Pharma L.P., NDA 022272) on abuse, misuse, and fatal and non-fatal overdose, associated with OXYCONTIN. The committees will discuss whether these studies, in concert with other information from the published literature, have demonstrated that the reformulated OXYCONTIN product has resulted in a meaningful reduction in these outcomes. The committees will also discuss the broader public health impact of OXYCONTIN’s reformulation.

Meeting Details:

On September 8, 2020, during session 1, the committee will discuss and make recommendations regarding the classification of facet screws systems which are currently unclassified pre-amendment devices to Class II (general and special controls). During session II, the committee will discuss and make recommendations regarding the reclassification of non-invasive bone growth stimulators which are currently post-amendment devices from Class III (general controls and premarket approval) to Class II (general and special controls). On September 9, 2020, the committee will discuss and make recommendations regarding the classification of three devices, which are currently unclassified pre-amendment devices to class II (general and special controls). The committee, during session I, will discuss semi-constrained toe (metatarsophalangeal) joint prostheses; during session II, will discuss intracompartmental pressure monitors; and during session III, will discuss intra-abdominal pressure monitoring devices. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

Meeting Details:

The meeting will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On August 31, 2020, the committee will discuss supplemental new drug application 209482/S-008, for TRELEGY ELLIPTA, a fixed-dose combination (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation), submitted by GlaxoSmithKline, for the following proposed labeling claim: Reduction in all-cause mortality in patients with chronic obstructive pulmonary disease (COPD). The focus of the discussion will be on the efficacy data submitted to support the proposed labeling claim, including the results from the Informing the Pathway of COPD Treatment trial and the influence of inhaled corticosteroids withdrawal on the results.