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Industry is asking the FDA to impose stricter requirements for outsourcing facilities to qualify for an exemption that allows them to produce near replicas of approved products. Read More
The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of setting out to accomplish new projects for this fiscal year – the final year of the five-year authorization for GDUFA. Read More
Generic drug makers would like a single point of contact for all four offices involved in inspections, an industry official told the GPhA Fall Technical Conference. Read More
Wrong telephone numbers, unsecure email addresses and inconsistent sponsor names are among the common mistakes the FDA sees in regulatory submissions for generics that can trigger delays in the review process. Read More