法规动态

The FDA has approved ANDA 084279 for a prescription oral tablet combining 500 mg probenecid and 0.5 mg colchicine, marketed by Actavis Pharma.

Experts argue that individual regulatory tweaks are insufficient and urge a dedicated law with clear standards to foster trust and activation of medical data under the Digital Healthcare Act.

The FDA has listed ANDA084743 for Inwood Labs' oral tablet of Phendimetrazine Tartrate (35 mg), currently marked as discontinued.

Cardinal Health reports a recall of Stryker's StrykeFlow PS devices after multiple complaints of handpiece leakage during use.

Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag failures that can cause device troubleshooting and temporary hemodynamic support gaps.

Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag component failures that can affect device performance.

Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.

Apotex Inc. has recalled lot 700059A of its Apo‑Semaglutide 2 mg pen after the dose window may incorrectly show a 2 mg dose, delivering 2 mg instead of the intended 0.25 mg or 0.5 mg.

TABLICAPS has filed ANDA085207 for an oral 0.25 mg Reserpine tablet, which is listed with a discontinued marketing status.

Sandoz's oral capsule product PHENDIMETRAZINE TARTRATE (35 mg) under application ANDA085702 has received FDA approval; the product is listed as discontinued.

Watson Labs' oral tablet GUANETHIDINE MONOSULFATE (product 001) is listed as discontinued in FDA records under ANDA 086114.

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.