West Virginia reaches $3.5M settlement with drug wholesaler

West Virginia officials have reached a $3.5 million settlement with a wholesaler accused of flooding the state with millions of prescription pain pills.  READ MORE

Could delayed replacement save key parts of Obamacare?

Republicans who have long called for repealing the Affordable Care Act are pushing for more transition time and delays as they realize the massive consequences of their proposals.  READ MORE

FDA Law Blog: January 03, 2017 In Time for the Holidays, FDA Grants PCPC’s Petition for Lead Levels in Lipstick and Externally Applied Cosmetics By Riëtte van Laack –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/01/in-time-for-the-holidays-fda-grants-pcpcs-petition-for-lead-levels-in-lipstick-and-externally-applie.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

FDA nails a third Wockhardt plant with a warning letter

January 3, 2017 | By Eric Palmer

The FDA sidelined U.S. biotech Cempra’s new generation antibiotic with a complete response letter last week over safety concerns, but also because of issues it has with the Wockhardt plant making the API for it. 

FDA slaps warning letter on Crescita plant sold by Valeant

United States: Fraud On The FDA Doesn't Fly Under The FCA Either

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Reed Smith

Ever since Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), held that state-law claims alleging fraud on the FDA are preempted, plaintiffs have been attempting to find some other way...

FDA Announces Implementation of GFI #213, Outlines Continuing Efforts to Address Antimicrobial Resistance

Today, the U.S. Food and Drug Administration announced that it has completed the implementation of Guidance for Industry #213, a process begun in 2013 to transition antimicrobial drugs with importance in human medicine (medically important antimicrobials) that are used in the feed or drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for production (e.g., growth promotion) purposes.

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December 22, 2016

Rock Solid Nutrition, LLC

Kansas City District Office

CGMP/Dietary Supplement/Adulterated/Misbranded

Not Issued *

December 23, 2016

Wockhardt, Ltd.

Center for Drug Evaluation and Research

CGMP/APIs/Adulterated

Not Issued *

Twelve Indicted in More than $100 Million Health Care Fraud involving prescribing compounded drugs

Twelve Indicted in More than $100 Million Health Care Fraud

Contemporary Clinic-2 hours ago

According to federal prosecutors, the scheme involved prescribing compounded drugs such as pain, scar, and migraine creams to military families covered by ...