Summary Company Announcement Date: June 08, 2022 FDA Publish Date: June 08, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination […]

Using its authority under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, FDA required extended-release/long-acting (ER/LA) opioid analgesic (OA) new drug application holders to […]

Docket Number: FDA-2022-D-1864 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guidance is intended to assist applicants who […]

Submission Process The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific […]

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA […]

Spotlight Events & Announcements Get Started with Your Submission The Innovative Science and Technology Approaches for New Drugs (ISTAND) Program accepts submissions for qualification of types […]

Image By: ShaAvhrée Buckman-Garner, M.D., Ph.D., Director of Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), and Mary Thanh Hai, M.D., Acting Director […]

GDUFA User Fee Rates Archive | FDA In this section: FDA User Fee Programs Home For Industry FDA User Fee Programs GDUFA User Fee Rates Archive […]

The time to act is now. We can and must prevent the next wave of the opioid crisis. Content current as of: 07/29/2025 Regulated Product(s)