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The FDA sent warning letters to four compounding pharmacies, reminding them of their obligations under federal law to compound drug products based on valid prescriptions, while one compounder told the agency it was exempt from the FDA’s GMP requirements. Read More
Senate Majority Leader Mitch McConnell (R-Ky.) said the FDA user fee reauthorization will be voted on before the Senate adjourns for its summer recess, scheduled to begin Aug. 14. Read More
Drug companies can streamline the development of new antibacterial drugs for seriously ill patients by applying less rigorous standards of effectiveness and more limited clinical trials than typical, the FDA said in guidance issued Aug. 1. Read More
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by Hospira. Read More
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
A third-party evaluator should be used to assess the expanded communications program proposed in the next generation of the FDA’s biosimilar user fees, according to BIO. Read More
As part of the Trump administration’s deregulatory push, the FDA has withdrawn nine planned regulations for the pharmaceutical industry, some in the works for years. Read More