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Latest From Joanne Eglovitch
ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.
PDA leaders weigh in on results of recent aseptic practices survey, saying pharmaceutical manufacturers may be carrying out certain aseptic practices to meet the expectations of regulators rather than the dictates of science. The survey also shows that despite adoption of technologies like RABS and isolators to keep workers away from sterile drug products, half the time they're still the root cause of contamination.
FDA has revised references in guidance to generic drug user fee requirements that changed under GDUFA II on Oct. 1. One guidance document no longer says for generics firms to pay user fees for prior approval supplement reviews. Another gives review goals for drug master file completeness assessments.
Having a multilayered approach to sterility assurance is key to preventing contamination in cleanrooms, with equal attention paid to gowning, aseptic technique, engineering technique and proactive and detailed trending, says Eli Lilly official. Official also advises manufacturers to follow both USP Chapter 1116 and the EU’s Annex 1 if they want their sterility assurance programs to pass muster with inspectors and do business globally.
An EU regulatory official is undeterred by pleas from industry to modify a requirement that manufacturers conduct pre-use, post-sterilization integrity testing of filters for sterile drugs under EU GMP Annex 1. The original annex required PUPSIT testing and the revision also is expected to require it. The revised annex has been repeatedly delayed, and now is expected early next year.
FDA has issued final guidance that clarifies the types of technologies eligible for acceptance into the agency's Emerging Technology Program. FDA also issues internal guidance to explain how reviewers should handle emerging technology applications.