Posted 28 April 2017
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May 8-9, 2017 - Pharmacy Compounding Advisory Committee
The Committee will review 6 bulk drug substances that have been nominated for inclusion on the section 503A Bulks List. The substances are as follows: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The Committee will also a class of oral solid modified release drug products that employ coated systems that were nominated for the Difficult to Compound List. The nominators are invited by the FDA to make short presentations supporting their nominations. The Committee will also hear a follow-up to discussions from previous meetings, including discussions about quality standards and conditions at compounding facilities.
May 10, 2017 - Medical Imaging Drugs Advisory Committee
The Committee will discuss a new drug application for 5-Aminolevulinic Acid Hydrochloride, an oral solution, by NX Development Corp., a proposed imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.
May 11-12, 2017 - Advisory Committee on Heritable Disorders in Newborns and Children
The meeting will include: (1) presentations and discussion on the process of identifying and following up on out of range newborn screening results; (2) a presentation on newborn screening quality assurance programs;(3) presentations on the clinical and public health impact of Critical Congenital Heart Defects screening; (4) discussion and possible vote on a report on Medical Foods for Inborn Errors of Metabolism; (5) a presentation, discussion, and possible vote on whether to move a nomination forward to evidence review for spinal muscular atrophy (SMA); and (6) updates from the Laboratory Standards and Procedures workgroup, Follow-up and Treatment workgroup, and Education and Training workgroup. The Committee will not be voting on a proposed addition of a condition to the Recommended Uniform Screening Panel (RUSP).
May 17, 2017 - Vaccines and Related Biological Products Advisory Committee
The Committee will discuss considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.
May 18, 2017 - Pediatric Advisory Committee and Pediatric Ethics Subcommittee
The Committees will discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled "A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy." The company conducting the trial, Sarepta Therapeutics, has stated the discussion will involve the use of ports in this trial.
May 24, 2017 - Oncologic Drugs Advisory Committee
During the morning session, the Committee will discuss a new drug application for neratinib that was submitted by Puma Biotechnology for the proposed indication as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy.
During the afternoon session, the Committee will discuss a new drug application for L-glutamine powder for oral solution, by Emmaus Medical, Inc., for the treatment of sickle cell disease.
May 25, 2017 - Oncologic Drugs Advisory Committee
The Committee will a discuss biologics license application) for a proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), by Hospira Inc., a Pfizer company.
May 25-26, 2017 - Secretary's Advisory Committee on Human Research Protections
The Committee will review recommendations pertaining to the Common Rule and the use of real-world evidence for devices.
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)].