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To help speed the approval of generics, the FDA Friday said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The FDA issued a draft guidance on the preliminary request for designation process, and what information to include. The pre-RFD process provides informal, non-binding feedback on the regulatory identity or classification of a drug, biologic or combination product. Read More
The FDA issued a draft and a separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs. Read More
The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures. Read More
The FDA will proceed with using a nonproprietary naming approach that relies on arbitrary four-letter suffixes to distinguish biosimilars and biologics, showing a disregard for industry concerns in a lightly tweaked final guidance that adds a few new considerations for suffix proposals. Read More
President-elect Donald Trump met with two west-coast venture capitalists Thursday who are being considered for top positions at the FDA, according to spokesman Sean Spicer. Read More