Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
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List of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s
The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false and misleading claims regarding compounded GLP-1 products offered on their websites.Biocon Biologics Limited – 09/03/2025
Biocon Biologics Limited – 09/03/2025. Country: India. Record Type: 483FDA Holds Meeting with States on Importation of Lower Cost Drugs
FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.Streamlined Trials Embedded in clinical Practice (STEP) Demonstration Project
C3TI aims to promote the adoption of pragmatic design in clinical trials and improve coordination and collaboration between CDER and sponsors to effectively support these innovative trials.FDA 483, dated June 11, 2008, (9 pages)
FDA 483, dated June 11, 2008, (9 pages)