R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

The REdI Fall 2016 Conference: Slides and Recordings

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The FDA holds these conferences only twice a year, which doesn't give medical device companies too much wiggle room when it comes to clearing their busy shedules to attend. So if you missed the conference, R&Q will fill you in!

Guidance document clean-up! - CDER

I read an interesting article on the RAPS website this morning about a new initiative set by the FDA to clean-up certain guidance documents. This means finalizing draft guidance documents, withdrawing or updating/revising outdated guidance documents. This initiative is taking place in the Center for Drug Evaluation and Research (CDER) department.

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