Winds of change, and literal winds, swirled this week. And autumn has finally arrived to Washington, D.C. Before you know it, we will be giving thanks at our tables and gearing up for to accomplish our frenzied holiday shopping. But for now, the weekend has arrived and it is time to look back at a bit of what happened – and I absolutely promise to bet some intervening postings this coming week. On the whole, it was a bit of a quiet week, but here are a few things of note.
- CDRH Publishes Guidance Agenda – Each year the guidance agenda gets published by the principle centers responsible for regulatory development in biologics, drugs and devices. CDRH this week posted its list in three sections – (1) those draft and final guidances it intends to put out; (2) those that it would like to put out and (3) those which it would like to revisit. In any case, the lists are aspirational and does not represent absolutes. That said, this has been a big era for devices – a category which includes not only genetically based tests, but apps and software-based medical support. In short, devices are undergoing rapid change. Among those final guidances FDA intends to issue were ones regarding the Breakthrough Devices Program, Expansion of the 510(k) program, Multiple Function Device Products and Clinical and Patient Decision Support Software. Among those drafts FDA aims to issue include one on Patient Engagement in Clinical Trials and Computer Software Assurance for Manufacturing. An accompanying blog posting by CDRH Director Dr. Jeff Shuren can be found here.
- Guidance on Generics of Complex Drugs – As FDA is winding up another banner year with respect to generic approvals, the agency is acting to further facilitate generic development. Commissioner Gottlieb issued a statement this week announcing a series of new guidance documents aimed at development of generic transdermal and topical delivery systems (TDS) which are applied to a patients’ skin to deliver drug into and through it. The new guidances are Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs and Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, along with two new product-specific guidance documents and 23 revised ones. The Commissioner signaled in his statement that the agency will follow up with even more policies to promote generic competition for complex drugs as well as other measures to address legal questions blocking generic development.
Things to Keep an Eye on This Week
- October 17 – FDA Oncology Center of Excellence Public Workshop – Sickle Cell Disease Clinical Endpoints
- October 17 – Joint Meeting of Gastrointestinal Drugs Advisory Committee with Drug Safety and Risk Management Advisory Committee – Consideration of sNDA for IBS Treatment
- October 18 – Gastrointestinal Drugs Advisory Committee – Consideration of NDA for treatment of chronic idiopathic constipation
Regulatory Developments in Pharma/Biotech/Devices/Food
- FDA Clears DNA-Based blood compatibility test
- Close AdComm vote on pain NDA
- FDA Issues Safety Communication on Cybersecurity of implantable cardiac devices