Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) I am delighted to once again help kick off this important conference. Its focus […]

Pharmaceutical quality provides the confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed. When CDER receives a prescription drug […]

For Immediate Release: May 28, 2024 Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat […]

Recognized Interpretive Criteria   Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm)Under Review Pathogen S I R S I R Staphylococcus aureus M100 standard is recognized Enterococcus […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]

The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of relevance to direct-to-consumer (DTC) and healthcare […]

CCN Final RuleConsumer-Directed AdvertisementsDrug of ChoiceDrug Name SizeFDA-Approved Launch Information“New”Package InsertsPost-marketing ReportingPresentation of InformationPress ReleasesPre-distribution SubmissionsReminder AdvertisementsMiscellaneous Questions CCN Final Rule When does the Clear, Conspicuous and […]

On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human […]

Docket Number: FDA-2024-D-1829 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides details about the […]