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2026년 8월 31일•1분 읽기
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.
규제 업데이트
2026년 8월 25일•1분 읽기
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.
규제 업데이트
2026년 8월 24일•1분 읽기
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.
규제 업데이트
2026년 8월 24일•1분 읽기
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).
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2026년 8월 24일•1분 읽기
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.
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2026년 8월 24일•1분 읽기
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Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.