Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made…

This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising,…

Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements needed for NDAs and ANDAs. Source:…

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,…

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…

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. Source: Drug Industry…

Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of…

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. Source: Drug Industry Daily

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…

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…