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The FDA’s Office of Generic Drugs received 57 ANDAs in January, marking a nearly 76 percent decrease in submissions from the previous month, when the agency experienced a surge in applications. Read More
The Trump administration is being sued over the president’s executive order requiring federal agencies to cut two regulations for every one they issue. Read More
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by the end of September. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
Generic drug applications surged in December, with the FDA receiving 235 ANDAs — the second-highest submission record for a particular month since the implementation of GDUFA. 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The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures.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 rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month. Read More