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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 and compete with branded and generic drugs. Read More
Working groups representing both the generic and brand-name pharmaceutical industries told the FDA they need more guidance on how generic versions of abuse-deterrent opioid medications will be reviewed and approved. 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
The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of introducing new priorities for this fiscal year — the final year of the five-year authorization for GDUFA I. Read More
A nearly two-year antitrust investigation by the Justice Department that involves more than a dozen generics makers could result in price-collusion charges before the year ends, according to a source familiar with the matter. Read More
The UK Court of Appeal affirmed an earlier ruling that invalidated Pfizer’s patent claims for Lyrica and ruled generics would not lead to infringements. Read More
Industry groups have endorsed the FDA’s commitment goals for BsUFA II, asking Congress to reauthorize the user fee program intended to improve review efficiency. Read More
The FDA’s commitment goals for GDUFA II were backed by industry at a recent meeting, bringing the user fee program closer to reauthorization. Read More