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Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements needed for NDAs and ANDAs. Read More
In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder cancer, a generic form of Narcan nasal spray, and a pediatric version of Lutahera — the first-ever radioligand approved for use in children. Read More
A Senate committee has demanded answers from Danish pharma Novo Nordisk on what it labels “astronomically” high prices for the company’s Ozempic/Wegovy (semaglutide) diabetes/weight loss drugs, while a report points to weight loss drugs as the driver for a massive spike in drug spending. Read More
The FDA is soliciting input from interested parties on policy topics the CDER Office of Clinical Pharmacology (OCP) could develop and implement to support drug development programs. Read More
Investigators found that the FDA OK’d nearly 80 percent of these non-supported surrogate markers as appropriate endpoints for a traditional approval. Read More
Most postmarketing requirements (PMR) and postmarketing commitments (PMC) for NDAs and BLAs were on-schedule in 2022, according to figures just released by the FDA. Read More
Answers to questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars have been issued by the FDA in a revised draft guidance. Read More
Peter Marks, director of CBER, is pushing to get more gene therapies targeting rare diseases to apply for accelerated approval (AA) to give the promising space a leg up in development. Read More
Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showing a strong association between the marker and relevant clinical endpoints, a new JAMA Network study says. Read More