Entries from HEALTH LAW SECTION BLOG tagged with 'REMS'

FDAAA requirements update: drug safety, clinical trials database

A Draft Guidance for Industry about Medication Guides and REMS has been published for comment purposes (February 2011); the draft Guidance indicates that it is intended to address 2 topics pertaining to Medication Guides for drug and biological products-that...

The FDA Postmarketing Drug Safety Information website

From the FDA news (1):On June 15, 2010, FDA began posting summaries of Agency safety analyses of recently approved drug and biologic products. These summaries are intended to share what the FDA has learned about the safety of products 18...

FDA's Quarterly Report: products and potential signals of serious risks/new safety information, AERS database.

Sept 5, 2008 FDA announced (1) that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.(2) The drugs have been identified based on a review of...

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