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...
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for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Obesity and Overweight: Developing...
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...
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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...
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...
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