For two decades, CDER has used certain methods to speed drug development and the regulatory review process so that promising therapies can get to patients faster.
Drug shortages have a significant impact on both hospitals and patients.
An audio podcast series featuring the Director of FDA Center for Drug Evaluation and Research
The Forum will focus on the latest trends and enhancements in laser-based imaging modalities such as Optical Coherence Tomography (OCT) and Adaptive Optics (AO), regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tool Program and the emerging role of Artificial Intelligence.
U.S. FOOD AND DRUG ADMINISTRATION: Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - March 19, 2019
On Tuesday, March 19, 2019, the FDA will host a webinar to share information and answer questions regarding the implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.”
U.S. FOOD AND DRUG ADMINISTRATION: The Least Burdensome Provisions: Concept and Principles Final Guidance - March 14, 2019
On Thursday, March 14, 2019, the FDA will host a webinar on the final guidance entitled, "The Least Burdensome Provisions: Concept and Principles."
U.S. FOOD AND DRUG ADMINISTRATION: Efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility
Advances in technology and material science are enabling new opportunities to transform health and mobility through innovations in medical products.
U.S. FOOD AND DRUG ADMINISTRATION: FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
At the FDA, protecting patient and consumer health is our highest priority.
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight
The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle.
U.S. FOOD AND DRUG ADMINISTRATION: FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines
A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality.