法规动态

FDA、EMA、TGA 及全球法规动态

#CGMP ×

2026年8月31日•1 分钟阅读

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.

2026年8月25日•1 分钟阅读

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.

2026年8月24日•1 分钟阅读

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.

2026年8月24日•1 分钟阅读

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).

2026年8月24日•1 分钟阅读

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.

2026年8月24日•1 分钟阅读

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Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.