The Center for Drug Evaluation and Research (CDER) Quantitative Medicine (QM) Center of Excellence (CoE) is established to facilitate and coordinate the continuous evolution and consistent […]

On This Page Date: August 16, 2024 Time: 9:00 AM – 4:00 PM ET Meeting Location FDA White Oak CampusBuilding 31, Conference Center, The Great Room10903 […]

Reference #: 3006895982 Product: Drugs Recipient: Recipient Name Dr. Jaidev Sanjeev Rajpal Recipient Title Managing Director & CEO Jubilant Generics Limited Plot No. 15, Knowledge Park […]

Delivery Method: UPS Reference #: 320-19-15 Product: Drugs Recipient: Recipient Name Mr. Pramod Yadav Recipient Title Chief Executive Officer Jubilant Generics Limited 1A, Sector 16ANoida 201301Uttar […]

Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal […]

For Immediate Release: April 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Summary Company Announcement Date: July 09, 2020 FDA Publish Date: July 24, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol […]

Summary Company Announcement Date: August 30, 2023 FDA Publish Date: August 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Label Mix-Up Company Name: […]

Drugs to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]