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by Pill Pals Customer Service | Jul 31, 2025 | News
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 are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or...by Pill Pals Customer Service | Jul 31, 2025 | News
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 conduct epidemiologic studies to 1) quantify the serious risks of misuse,...by Pill Pals Customer Service | Jul 31, 2025 | News
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 of Office of New Drugs, CDERThe U.S. Food and Drug Administration recognizes that...by Pill Pals Customer Service | Jul 31, 2025 | News
Spotlight Events & Announcements Get Started with Your SubmissionThe Innovative Science and Technology Approaches for New Drugs (ISTAND) Program accepts submissions for qualification of types of drug development tools (DDTs) that are out of scope for existing DDT...by Pill Pals Customer Service | Jul 31, 2025 | News
Summary Company Announcement Date: July 30, 2025 FDA Publish Date: July 31, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Doehler Dry...