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FDA
FDA Announces Draft MDUFA Agreement
On August 22, FDA and representatives from the medical device industry and laboratory community announced an agreement in…
FDA “Revolving Door” Gets Slammed
Last week, several news outlets wrote articles about the “revolving door” at the United States Food and Drug Administration (FDA),…
Prescriber Education Campaign on Opioids Launched
We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse…
FDA Offers Update to Orange Book Website
In August 2016, the Food and Drug Administration (FDA) launched an updated web-based version of its “Orange Book,” the publication…
FDA and CMS Call for Nationwide Changes
Recently, CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert Califf wrote a joint letter to Gary Beatty, Chair of the…
FDA Commissioner Califf at BIO
The Biotechnology Innovation Organization (BIO) held an International Convention in San Francisco June 6 – 9, 2016. This year, the…
FDA Guidance Data Integrity and Compliance With CGMP
In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations involving data integrity…
FDA: Draft Guidance – Procedures for Evaluating Appearance Issues and…
FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members…
Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA…
In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO…
Industry Expresses Concerns About FDA DTC Study
AbbVie, Eli Lilly, and Merck are all raising questions about the Food and Drug Administration's (FDA) plan to…