Regulatory Updates
Aug 30, 2026•1 min read
FDA approves labeling and manufacturing updates for ISOPAQUE 280 (NDA 017506)
The FDA has approved labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.
Regulatory Updates
Aug 30, 2026•1 min read
MHRA Safety Roundup – Latest Advice for Medicines and Devices
A brief summary of the MHRA’s latest safety advice for medicines and medical device users.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Recall Issued Due to Lack of Assurance of Sterility
The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.
Regulatory Updates
Aug 30, 2026•1 min read
Gyeonggi‑Do Pharmacy Association Council Calls for Withdrawal of Govt Plan to Expand Convenience‑Store OTC List
The Gyeonggi‑do Pharmaceutical Association sub‑chapter chairpersons council strongly opposes the Ministry of Health’s proposal to increase convenience‑store OTC safety medicines from 13 to 20 items, calling it a hasty policy that threatens public safety.
Regulatory Updates
Aug 30, 2026•1 min read
KRPIA Welcomes First Joint Drug Review via EMA's OPEN Program
KRPIA praised MFDS for completing the first joint pharmaceutical review with overseas regulators through EMA's OPEN program, marking a milestone in Korea‑EU collaboration.
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Regulatory Updates
Aug 28, 2026•1 min read
FDA Approves Generic Levetiracetam Tablets (ANDA078993)
The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.
Regulatory Updates
Aug 25, 2026•2 min read
EMA CHMP July 2026 Meeting Recommends 12 New Medicines and Multiple Extensions
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended twelve new medicines for approval and issued several positive, negative and withdrawal decisions on other products.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Recall D-0296-2023 Issued Over Lack of Sterility Assurance
The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA July 2024 Drug Safety Update – Letters and Recalls Summary
The MHRA’s July 2024 update provides a concise summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Identifies GMP Violations Affecting Sterility Assurance
An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.
Regulatory Updates
Aug 24, 2026•1 min read
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).
Regulatory Updates
Aug 24, 2026•1 min read
FDA Recall: Incorrect Expiration Date on Product Bottles
The FDA has issued a recall for bottles labeled with an incorrect expiry date of 11/2016; the correct date should be 09/2016.