The FDA cited ADMA Biologics for failure to implement proper document controls and prevent unauthorized changes to data in its computer systems. Source: Drug Industry Daily

The U.S. Court of Appeals for the Federal Circuit Friday denied a request by generic drugmakers for a rehearing to challenge an epilepsy drug patent’s validity. Source: Drug Industry Daily

FDA draft guidance on assessing a new drug’s impact on blood pressure does not adequately explain the agency’s thinking on the use of smaller clinical trials and should incorporate a…

The FDA is proposing to exclude three substances from its 503B Bulks List of substances for outsourcing facilities to use in compounding drugs — including one that’s the subject of…

The Senate passed an amendment Thursday to require drugmakers to list prescription drug prices in direct-to-consumer ads in an effort to promote lower prices through increased transparency. Source: Drug Industry…

The FDA rapped finished drugmaker Higiene + Salud for shoddy recordkeeping and deficient investigations after a November inspection of the company’s Toluca, Mexico facility. Source: Drug Industry Daily

A federal appeals court affirmed last week that Novartis did not engage in antitrust violations to protect a patent on its leukemia drug Gleevec (imatinib). Source: Drug Industry Daily

A coalition of health care stakeholders called on the FDA to issue final guidance on interchangeable biosimilars to help promote drug price competition, saying the agency’s failure to finalize its…

A panel of experts is urging the FDA to reconsider rigid rules excluding certain groups from clinical trials — or at least make decisions on a case-by-case basis. Source: Drug…

In its latest move to combat opioid abuse, the Justice Department slapped two Ohio doctors with restraining orders after a sting operation found they illegally prescribed opioid painkillers and other…