by Pill Pals Customer Service | Mar 28, 2025 | News
CDER Center for Clinical Trial Innovation (C3TI) Content current as of: 03/28/2025 Regulated Product(s) Topic(s)...
by Pill Pals Customer Service | Mar 28, 2025 | News
[03/28/2025] FDA has identified significant data integrity and study conduct concerns with bioequivalence studies conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India. Information for sponsors The agency has...
by Pill Pals Customer Service | Mar 27, 2025 | News
Summary Company Announcement Date: March 26, 2025 FDA Publish Date: March 27, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Frito-Lay Brand Name: Product Description: Product Description...
by Pill Pals Customer Service | Mar 27, 2025 | News
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) is a central hub that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development. C3TI aims to promote existing CDER...
by Pill Pals Customer Service | Mar 27, 2025 | News
Summary Company Announcement Date: March 27, 2025 FDA Publish Date: March 27, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Cromer Food Services, Inc. Brand Name: Brand Name(s) CFS Cromer Food...
by Pill Pals Customer Service | Mar 27, 2025 | News
STN #s: BL 125094 – Anti-A (Murine Monoclonal) (Formulated for Automated Testing)BL 125096 – Anti-A, B (Murine Monoclonal) (Formulated for Automated Testing)BL 125097 – Anti-D (Monoclonal) (IgM) (Formulated for Automated Testing)BL 125098 –...
by Pill Pals Customer Service | Mar 27, 2025 | News
On This Page Date: May 5, 2025 Time: 8:00 a.m. – 5:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the...
by Pill Pals Customer Service | Mar 27, 2025 | News
On This Page Location DetailsThe Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MDEvent DetailsThe In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence...
by Pill Pals Customer Service | Mar 27, 2025 | News
Strategic PlanCDER’s approach to data standards consists of four strategic goals:Support open, consensus-based data standards developmentMaintain and promote a well-defined data standards governance functionPromote the electronic submission of regulatory data using...
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