FDA Advisory Committee Calendar

Posted 17 July 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

FDA Adcomm July 2017

July 26, 2017 – Anesthetic and Analgesic Drugs Advisory Committee and Risk Management Advisory Committee

The Committees will discuss a new drug application for oxycodone hydrochloride extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter 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, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

July 28, 2017 - Vaccines and Related Biological Products Advisory Committee

Dynavax Technologies Corporation has announced an Advisory Committee meeting for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)].

August 2, 2017 - Arthritis Advisory Committee

The Committee will discuss a BLA for sirukumab injection (proposed trade name PLIVENSIA), submitted by Janssen Biotech, Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have5had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. The discussion will include dose selection, efficacy, radiographic progression study, and safety.

August 3, 2017 – Arthritis Advisory Committee

The Committee will discuss supplemental new drug applications (sNDAs) for XELJANZ (tofacitinib) tablets and XELJANZ XR (tofacitinib) extended-release tablets submitted by Pfizer Inc. for the treatment of adult patients with active psoriatic arthritis. The Committee will discuss the efficacy and safety data and benefit-risk considerations.

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Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER

Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees

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