Regulatorische Updates

The FDA has approved labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.

A brief summary of the MHRA’s latest safety advice for medicines and medical device users.

The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.

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.

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.

The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.

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.

The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.

The MHRA’s July 2024 update provides a concise summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.

The FDA has initiated a recall of a product because of deviations from current Good Manufacturing Practices (CGMP).

The FDA has issued a recall for bottles labeled with an incorrect expiry date of 11/2016; the correct date should be 09/2016.