規制動向
2026年8月31日•1分で読めます
HLB liver cancer drug approval delayed again over cGMP manufacturing issue
FDA issued a Complete Response Letter for HLB’s ribociclib NDA, citing cGMP deficiencies at the Chinese Hengrui manufacturing site.
規制動向
2026年8月25日•1分で読めます
FDA Recall: Products Exposed to Improper Temperatures (D-0179-2024)
The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.
規制動向
2026年8月24日•1分で読めます
FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions
The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.
規制動向
2026年8月24日•1分で読めます
FDA Recalls Product Due to CGMP Deviations
The FDA has initiated a recall of a product because of deviations from current Good Manufacturing Practices (CGMP).
規制動向
2026年8月24日•1分で読めます
FDA Recalls Products Due to Contaminated Excipient from Supplier
The FDA has issued a recall for products manufactured with a contaminated excipient that was previously recalled by the supplier, citing CGMP deviations.
規制動向
2026年8月24日•1分で読めます
FDA Recalls Next Advanced Antibacterial Hand Sanitizer Over Methanol Contamination
FDA recalls Next Advanced Antibacterial Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.