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FDA
FDA Off-Label Hearing: Day One
Yesterday, the Food and Drug Administration (FDA) kicked off a two-day public meeting to review the extent to which off-label…
FDA Open to Biomarker Comments
FDA has announced the opening of a docket for interested parties to submit suggestions, recommendations, and comments on a…
FDA Issues Draft Guidance on Real-World Data
In September, FDA issued a draft guidance to clarify how it evaluates real-world data to determine whether it can be used in FDA…
Biosimilar User Fee Act (II) Performance Goals Letter Issued
The United States Food and Drug Administration (FDA) recently released its performance goals and procedures for fiscal years 2018…
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…