Indian firm's invalidated out-of-specification rate was too high, FDA suggests in heavily redacted Form 483 report. This rate, which also came up in two recent warning letters, happens to be one of the three rates the USagency wants to use as quality metrics for deciding how soon investigators should revisit sites.
FDA has cited a manufacturer in India for performing poorly on one of the three metrics the agency has proposed to use in rating the quality of drug manufacturing facilities.
This suggests that even if industry forces FDA to delay its quality metrics initiative, the agency nevertheless can and will...
Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
