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Following FDA inspections and a warning letter, the Department of Justice filed a civil complaint against the outsourcing facility Cantrell Drug Company, of Little Rock, Arkansas seeking a preliminary injunction to halt manufacturing and order the company to recall and destroy all drugs compounded, held or distributed. Read More
A Valeant Pharmaceuticals unit agreed to pay $58 million to settle multi-district litigation that accused it of violating antitrust laws to keep generic versions of Solodyn off the market. Read More
Attorney General Jeff Sessions directed the Drug Enforcement Agency to evaluate the possibility of lowering caps on opioid production for drugmakers. Read More
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain — one recommending data and documentation practices and another defining terms such as “suspect products” and “illegitimate products.” Read More
The amendments include a recommendation that sponsors document their rationale for choosing on-site or centralized monitoring or a combination of the two. Read More