FDA: Review of Advisory Committees 2008-2012, Fewer Meetings and More…
Over the years, we have written about the FDA's Advisory Committees with a special interest on "conflict of interest"…
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December 2015
Update on Risk Evaluation and Mitigation Strategies
For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act…
FDA Pushes Back Release of Generic Drug Safety Label Rules
The United States Food and Drug Administration (FDA) has once again pushed back the release of a final rule allowing…
Senate Aging Committee Hearing on Drug Prices: Faster Generics Approval…
The Senate Special Committee on Aging held a hearing on Wednesday, December 9, 2015, to discuss "Sudden Price Spikes in…
Major Drug Pricing Ballot Initiatives Face 2016 Voters
As many of our readers know, drug prices have been in the news for several months now, with many public figures voicing…
2015 Whistleblower Update
The annual report released by the SEC Office of the Whistleblower for the 2015 fiscal year showed an increase in Foreign…
Concerns Over Valeant Lead to Troubles for Other Companies
With Valeant facing constant criticism about their business model, other pharmaceutical companies following similar…
Health and Human Services Drug Pricing Forum
The Department of Health and Human Services recent Forum on Prescription Drug Prices, where they encouraged stakeholders…
Sanofi Corporate Integrity Agreement 2015
Sanofi recently signed their latest Corporate Integrity Agreement (CIA) to settle the latest round of charges of…
Life Science Compliance Update December 2015 Issue: Back to the Future
The December 2015 issue of Life Science Compliance Update, available with a subscription here, offers a more in-depth…