Weekly Roundup 10.12.18

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

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices/Food

Photo by Annie Spratt on Unsplash

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