Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 25, 2026•1 min read
FDA Recalls Drug Over Adulterated API and Content Uniformity Failure
The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.
Regulatory Updates
Aug 25, 2026•1 min read
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.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA Summary of Recent Medicine and Device Safety Letters
The MHRA has released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Regulatory Updates
Aug 25, 2026•1 min read
Warfarin and Tramadol Interaction Raises Bleeding Risk – MHRA Alert
MHRA warns that combining warfarin with tramadol can elevate INR, leading to severe bruising, bleeding and potentially fatal outcomes.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA Issues New Safety Measures: Topiramate Contraindicated in Pregnancy
Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless a Pregnancy Prevention Programme is followed, per MHRA review.
Regulatory Updates
Aug 25, 2026•1 min read
PMDA Publishes Post‑Marketing Drug Safety Information
The PMDA and Japan's Ministry of Health, Labour and Welfare provide a webpage with drug risk information under review, noting possible translation inaccuracies and untranslated files.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA Drug Safety Update: June 2024 Letters and Notifications
The MHRA released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA warns Epimax ointments may cause ocular surface toxicity if applied to face
MHRA advises against prescribing Epimax Ointment or Epimax Paraffin‑Free Ointment for facial use due to reports of eye injury.
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 25, 2026•1 min read
MHRA August 2024 Drug Safety Update: Summary of Letters and Recalls
The MHRA released a summary of letters and notifications sent to healthcare professionals in August 2024 regarding medicines and medical devices.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA Drug Safety Update: September 2024 Letters & Recalls
MHRA released a summary of recent letters and notifications to healthcare professionals concerning medicines and medical devices for September 2024.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA advises blood pressure monitoring for bromocriptine patients
MHRA safety review recommends blood pressure monitoring for patients on bromocriptine following a Yellow Card report.