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

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of three generics to treat HIV. Read More

Generics makers want to be able to phone a single designated official at the FDA to discuss their ANDAs, but the FDA doesn’t agree. 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

The European Commission is recommending that countries promote the use of generics and biosimilars to reduce EU drug spending. 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

The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More

The FDA’s draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments. Read More

The International Council for Harmonisation identified the key scientific issues facing drug developers in pediatric indications in a draft updating its 16-year-old E11 guideline. Read More

The FDA is recommending that sponsors submit more detailed race and ethnicity data with their applications, compared to recommendations from a previous international harmonization guideline. Read More