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...
by Pill Pals Customer Service | Jul 31, 2025 | News
Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial...
by Pill Pals Customer Service | Jul 31, 2025 | News
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 review of certain novel excipients (inactive...
by Pill Pals Customer Service | Jul 31, 2025 | News
Submission ProcessThe 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or...
by Pill Pals Customer Service | Jul 30, 2025 | News
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 FDA User Fee Programs Generic Drug User Fee Rates for Fiscal Year 2025Generic Drug User Fee Rates for Fiscal Year 2024Generic...
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