Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week FDA again continued its flood of end-of-year guidances, the agency’s device center published a global harmonization plan, and Novo Nordisk had a particularly tough week.
It’s been another busy week for the US Food and Drug Administration (FDA) as it continued to publish a tranche of guidances, including guidances on how agency staff may use alternative tools to inspect drug manufacturing facilities and conduct formal meetings with drug sponsors. The agency also published guidances covering topics such as prescription drug use-related software, biosimilar labeling, and clinical trials.
In a request for information (RFI), FDA wants to hear from stakeholders about the challenges and opportunities they face when developing individualized cell and gene therapies. The agency wants to hear about issues such as manufacturing, nonclinical development, clinical development, and toxicology.
FDA said its Office of Women’s Health and Office of Clinical Pharmacology will hold a virtual workshop on 11 October to discuss the potential impact menopause may have on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response to drugs and biologics currently on the market. Presenters are expected to talk about issues such as how menopause may affect drug absorption, distribution, and metabolism and identify potential areas for further research…
