-
The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.
-
Quality and Regulatory Predictability: Shaping USP Standards – 12/11/2025
This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. -
Guidance: Early Access to Medicines Scheme: Overview
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeutics.
-
ByHeart Broadens Voluntary Recall While Investigation Continues
[New York, NY] – ByHeart, a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and -
IBSPOT.com Inc. – 715657 – 10/27/2025
Unapproved New Drugs/Misbranded -
Miers Laboratories, Ltd – 715378 – 11/03/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Taizhou Kangping Medical Science and Technology Co., Ltd. – 711081 – 10/09/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Field Safety Notices: 3 to 7 November 2025
List of Field Safety Notices from 3 to 7 November 2025.
-
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
-
MHRA-led study reveals major inconsistencies in global microbiome research
International collaboration establishes new quality standards to improve reliability of gut health studies – improving accuracy to provide better diagnosis and treatment.
-
Konrad Rejdak, MD, PhD – 671405 – 05/01/2025
Bioresearch Monitoring Program/IRB -
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
