by Pill Pals Customer Service | Aug 1, 2025 | News
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 Company Name: Plastikon Healthcare, LLC Brand Name: Product Description: Product...
by Pill Pals Customer Service | Aug 1, 2025 | News
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind...
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...
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