FDA Advisory Committee Calendar

Posted 04 October 2017 By Tarius

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

To contact the writer of this article directly, please send an email to sactracker@tarius.com.

Upcoming Meetings

Adcomm Calendar - October 2017 2

October 4, 2017 – Vaccines and Related Biological Products Advisory Committee

The Committee will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern hemisphere influenza season.

October 12, 2017 - Cellular, Tissue, and Gene Therapies Advisory Committee

The Committee will discuss and make recommendations on the safety and effectiveness of voretigene neparvovec by Spark Therapeutics, Inc. The proposed indication is for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.

October 13, 2017 – Dermatologic and Ophthalmic Drugs Advisory Committee

The Committee will discuss the safety and efficacy of a new drug application for netarsudil ophthalmic solution 0.02%, submitted by Aerie Pharmaceuticals Inc., for the proposed indication to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

October 18, 2017 – Endocrinologic and Metabolic Drugs Advisory Committee

The Committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

October 31, 2017 – Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The Committees will discuss new drug application (NDA) 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.

November 1, 2017 – Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The Committee will discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence.

November 7, 2017 – Vaccines and Related Biological Products Advisory Committee

The Committee will discuss and make recommendations on the clinical development plan for Pfizer's investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations.

November 16, 2017 – Antimicrobial Drugs Advisory Committee

The Committee will discuss a new drug application for ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.

December 7, 2017 - Bone, Reproductive and Urologic Drugs Advisory Committee     

The Committee will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The Committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.

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