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Upcoming Meetings

12 September – Pharmacy Compounding Advisory Committee

The Committee will receive information on the following two issues to follow-up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the Committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The list below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

20 September – Pediatric Advisory Committee

The Committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). In addition, the FDA will give updates on general safety topics that pertain to the FDA Adverse Event Reporting System (FAERS), the generic drug approval process and labeling updates for EXJADE (deferasirox) and inhaled corticosteroid long-acting b-2 agonists. This meeting is the rescheduling of the meeting that was planned for March 23, 2018 but was postponed.

20 September – Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The meeting will focus on two topics related to the Office of Pharmaceutical Quality's priority of promoting the availability of better medicine. During the morning session, the Committee will discuss the modernization of generic drug applications through a Knowledge-aided Assessment & Structured Application (KASA) initiative. During the afternoon session, the Committee will discuss in-vitro/in-vivo relationship standards, and the FDA will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

3 October – Vaccines and Related Biological Products Advisory Committee

The Committee will make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 southern hemisphere influenza season.

10 October – Oncologic Drugs Advisory Committee

The Committee will discuss the resubmission of a biologics license application (BLA) for CT-P10, a proposed biosimilar to Rituxan (rituximab) by Celltrion, Inc.

 11 October – Anesthetic and Analgesic Drug Products Advisory Committee

The Committee will discuss a new drug application for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The Committee will also discuss the efficacy and safety data and benefit - risk considerations.

12 October – Anesthetic and Analgesic Drug Products Advisory Committee
The Committee will discuss a new drug application for sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The Committee will also be asked to discuss risk-benefit considerations and whether this product should be approved.

17 October – Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The Committees will discuss a supplemental new drug application for  ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

18 October – Gastrointestinal Drugs Advisory Committee

The Committee will discuss a new drug application for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults.