The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Source: Drug Industry Daily
The Department of Justice has made another move against a drugmaker in its investigation of an alleged industry-wide kickback scheme, accusing Teva Pharmaceuticals of funneling kickbacks for its multiple sclerosis…
Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released…
The FDA has slapped Eosera with a Form 483 after finding the over-the-counter (OTC) ear-care product manufacturer failed to validate drug products and properly investigate bacterial contamination. Source: Drug Industry…
With just six months to go before the end of the transition period in the UK’s exit from the European Union, European drug industry groups said they are “extremely concerned”…
The FDA on Friday released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Source: Drug Industry Daily
The FDA hit a Paterson, New Jersey contract testing laboratory with a warning letter for active pharmaceutical ingredient (API) testing violations. Source: Drug Industry Daily
Insmed is sponsoring a clinical trial in the UK of its bronchial drug Brensocatib as a potential COVID-19 treatment. Source: Drug Industry Daily
The state of New York has filed civil charges against Mallinckrodt for its alleged role in the opioid epidemic. Source: Drug Industry Daily
AstraZeneca has begun a phase 3 clinical trial to evaluate its diabetes drug Farxiga (dapagliflozin) as a possible treatment for hospitalized COVID-19 patients. Source: Drug Industry Daily