eBPDR System Instructions

by Pill Pals Customer Service | Mar 17, 2025 | News

For use by manufacturers to report biological product deviations (BPD) to the Center for Biologics Evaluation and Research (CBER) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also, for use...

Increased Recognition of Human Anaplasmosis, Ontario, Canada, 2021

by Pill Pals Customer Service | Mar 17, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Queen’s University, Kingston, Ontario, Canada (C. Dai, D. Good, E. Wilson,...

Yellow Fever Virus in Mosquitoes from Rainforest Bordering Manaus, Brazil, 2022

by Pill Pals Customer Service | Mar 17, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: São José do Rio Preto School of Medicine, São José do Rio Preto, Brazil...

Savage Pet Recalls Savage Cat Food Chicken – Large and Small Boxes Because of Possible Bird Flu Health Risk

by Pill Pals Customer Service | Mar 16, 2025 | News

Summary Company Announcement Date: March 15, 2025 FDA Publish Date: March 15, 2025 Product Type: Animal & Veterinary Reason for Announcement: Recall Reason Description Possible Bird Flu Health Risk Company Name: Savage Pet Brand Name: Product Description: Company...

Seabear Company Recalls Smoked Salmon Chowder and Alehouse Clam Chowder Because of Possible Health Risk

by Pill Pals Customer Service | Mar 15, 2025 | News

Summary Company Announcement Date: March 15, 2025 FDA Publish Date: March 15, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential contamination with Clostridium botulinum Company Name: Seabear Company Brand Name:...

Products Approved for Anthrax

by Pill Pals Customer Service | Mar 15, 2025 | News

Image Anthim (obiltoxaximab) injection, for intravenous useAnthrasil [Anthrax Immune Globulin Intravenous (Human)], sterile solution for infusion (CBER)Biothrax (Anthrax Vaccine Adsorbed) (CBER)Ciprofloxacin Cyfendus (FDA approved 7/20/2023)Doxycycline and Other...

Drug Safety Oversight Board Meetings

by Pill Pals Customer Service | Mar 15, 2025 | News

Drug Safety Oversight Board Meetings – Public Summaries | FDA Source

Frequently Asked Questions About Therapeutic Biological Products

by Pill Pals Customer Service | Mar 14, 2025 | News

These frequently asked questions have been developed for the CDER Small Business and Industry Assistance Web site to help small pharmaceutical businesses understand the regulatory process for therapeutic biological products.What is a biological product? Biological...

Novel Drug Approvals at FDA

by Pill Pals Customer Service | Mar 14, 2025 | News

What are “Novel” Drugs?”Novel” drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. Helping Guide the Way for New MedicinesInnovative drugs...