Posted 17 July 2017
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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.