FDA Commissioner Scott Gottlieb highlighted the agency’s plans to expand data collection on adverse event reporting in his Feb. 27 testimony before a key House appropriations subcommittee. Source: Drug GMP…
The FDA issued Form 483 reports to a trio of drugmakers for various quality issues observed during inspections. Source: Drug GMP Report
The FDA issued a series of warning letters to three foreign and two U.S. drugmakers, faulting them for violations ranging from inadequate aseptic processing areas to use of APIs subject…
Petitions aimed at delaying approvals of competing drugs are diverting resources away from the agency’s public health efforts, the FDA said in a report to Congress. Source: Drug GMP Report
FDA Commissioner Scott Gottlieb said that the agency is ramping up its efforts to improve public warnings and recall notifications. Source: Drug GMP Report
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Source: Drug GMP Report
A federal judge ruled Teva can’t challenge the FDA’s new policy on generic exclusivity because the drugmaker has not proved a danger of imminent injury. Source: Drug Industry Daily
The FDA hit Canadian drug distributor CanaRx with a warning letter, citing the company for supplying unapproved versions of FDA-cleared drugs. Source: Drug Industry Daily
The FDA’s Office of Generic Drugs released its annual report for 2018, highlighting a steady increase in first-time generic approvals and the green lighting of more than 1,000 generic drugs.…
The FDA issued a warning letter to an OTC drug manufacturer in Catalonia, Spain, for inadequate testing of released drug products and incomplete batch records. Source: Drug Industry Daily