Regulatorische Updates

The MHRA urges healthcare professionals to support new guidance on reporting suspected adverse incidents related to insulin pumps and CGM devices.

Healthcare professionals should inform patients of common and serious side effects of GLP‑1 receptor agonists.

FDA has recalled a product after routine stability testing revealed visible foreign substances, including heavy metals such as chromium and titanium, and inactive components.

The MHRA released a summary of letters and notifications regarding medicines and medical devices sent to healthcare professionals in October 2024.

The MHRA has released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.

The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.

The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.

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

The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.

FDA recall (D-1035-2017) reports cartons labeled as Amantadine HCl 100 mg capsules actually contain Cyclobenzaprine HCl 5 mg tablets due to a labeling error.

The MHRA released a summary of letters and notifications sent to healthcare professionals about medicines and medical devices in December 2024.