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Considerations for Including Tissue Biopsies in Clinical Trials

by Pill Pals Customer Service | Jun 4, 2025 | News

Docket Number: FDA-2024-D-2402 Issued by: Guidance Issuing Office Oncology Center of Excellence This guidance provides recommendations to industry, investigators, institutions, and institutional review boards (IRBs) regarding considerations for tissue biopsies that...

Developing Products for Weight Management

by Pill Pals Customer Service | Jun 4, 2025 | News

Docket Number: FDA-2007-D-0435 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Obesity and Overweight: Developing...

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole

by Pill Pals Customer Service | Jun 4, 2025 | News

Summary Company Announcement Date: June 02, 2025 FDA Publish Date: June 04, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Amneal Pharmaceutical LLC Brand Name: Product Description: Product...

Transfer of a Premarket Notification (510(k)) Clearance Guidance

by Pill Pals Customer Service | Jun 4, 2025 | News

Submit Comments by 08/04/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

Advancing Health Through Innovation

by Pill Pals Customer Service | Jun 4, 2025 | News

INNOVATION PREDICTABILITY ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2023Director’s Message Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research Welcome to FDA’s Center for Drug Evaluation and Research’s (CDER) 12th iteration...