With Shutdown Over, FDA Posts Torrent of Updates to Federal Register

It's been a slow month for regulatory policy-making in the US, with the 16-day government shutdown all but stifling the development and publication of any regulation, guidance document, or meeting request. Close watchers of Focus' Federal Register Tracking Tool will have noticed that FDA last posted an update to the Federal Register on 2 October 2013, and then nothing in the subsequent 20 days.

But now with the government shutdown over and regulators back at their posts, the flow of documents to the Federal Register is resuming, and fast.

The 22 October 2013 posting of the Federal Register shows a whopping 15 documents set for publication, constituting the highest single-day amount of the 2013 Calendar year.

Among the postings are several guidance documents FDA has already published on its website:

• Acute Bacterial Skin and Skin Structure Infections; Developing Drugs for Treatment
• Chronic Hepatitis C Virus Infection; Developing Direct-Acting Antiviral Drugs for Treatment
• Elemental Impurities; International Conference on Harmonisation
• Annex 14 on Bacterial Endotoxins Test General Chapter
• Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine

In addition, FDA's Federal Register postings also include four new or rescheduled advisory committee meetings:

• Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee (Cochlear Americas' Nucleus Hybrid L24 Implant System - 8 November 2013)
• Endocrinologic and Metabolic Drugs Advisory Committee (BioMarin Pharmaceutical's Vimizim - 19 November 2013)
• Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (Pediatric Written Requests for Bristol-Myers Squibb and Merck Sharp & Dohme, as well as a pediatric development plan by Novartis - 5 November 2013)
• Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (General discussion of the challenges associated with patient reported outcomes in the pediatric age group as it related to oncology products - 4 November 2013)

Further, four products were taken off the market by FDA:

• GlaxoSmithKline's Bexxar (for one indication)
• Intal (Cromolyn Sodium) Inhalation Capsule, 20 mg (Not for reasons of safety or effectiveness)
• Paraflex (Chlorzoxazone) Tablets, 250 mg (Not for reasons of safety or effectiveness)
• Potassium Citrate (10/20 mg per packet) (Not for reasons of safety or effectiveness)

All of FDA's updates may be found on its Federal Register page.