The FDA served U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing,…
The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Collegium Pharmaceutical of Canton, Massachusetts for downplaying the risks of its extended release opioid drug Xtampza ER in…
A federal judge ruled in favor of the FDA’s decision to deny Amgen market exclusivity for the pediatric dialysis drug Sensipar (cinacalcet), saying the company failed to prove the FDA…
Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the…
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes…
PhRMA, Merck and Illumina offered feedback on the FDA’s draft guidance on the development of treatments that target diseases caused by molecular alterations, requesting the agency provide more details. Source:…
Allergan, Senju and Kyorin agreed to pay pharmaceuticals purchaser Hartig Drug $9 million to settle a product -hopping class-action lawsuit. Source: Drug Industry Daily
The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold…
A federal judge overturned a $2.5 billion patent infringement verdict, the largest ever in a U.S. patent case, against Gilead Sciences in a dispute with Merck. Source: Drug Industry Daily
Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups…