The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work…

The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Source:…

The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a report released Tuesday. Source: Drug Industry Daily

The FDA on Tuesday announced that it will strengthen current warnings in the prescribing information for fluoroquinolone antibiotics regarding potential mental health side effects and blood sugar disturbances. Source: Drug…

Sponsors should rely on “several” animal studies to test the efficacy and safety of any smallpox treatments, the FDA says in a new draft guidance issued Tuesday. Source: Drug Industry…

The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results…

The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil). Source: Drug Industry Daily

A newly-unsealed lawsuit by the state of Tennessee alleges Purdue violated a 2007 settlement with the state and continued to use providers with histories of misconduct to provide its products.…

FDA officials will work with medical societies to come up with opioid-prescribing guidelines that regulators hope will strike a balance between the needs of chronic pain suffering and the need…

President Trump on Monday blasted Pfizer and other drug companies for hiking drug prices “for no reason.” Source: Drug Industry Daily