FDA Recent Drug Approvals

CBER Guidances Cover Genome Editing, Patient Preference, April 2026

FDA published a listing of 12 recently issued guidance documents from CBER, CDER, CDRH, CVM, and ORA covering the period January–April 2026. Topics include genome editing safety assessment, voluntary patient preference information, cybersecurity in medical devices, clinical decision support software, biosimilar development, Bayesian methodology in clinical trials, and Computer Software Assurance. Nine of the 12 documents are Draft Guidances, and three are final Q&A documents. Regulated firms developing biologics, drugs, or medical devices should review these documents to identify guidance that may affect current development programs.

Resources for Assessing Drug Risks and Benefits

FDA's Center for Drug Evaluation and Research (CDER) published a resource page consolidating links to drug safety information tools, including Drug Safety Communications, MedWatch adverse event reporting, Drug Alerts and Statements, and post-market safety resources. The page also provides access to FDA drug databases (Drugs@FDA, Orange Book, Drug Shortages, NDC Directory), FDALabel, compounding information, and medication error resources. Contact information for the Division of Drug Information is provided for healthcare professionals seeking additional guidance.