EMA Outlines 60-Day Process for Postmarket Safety Inquiries

If an EU nation finds a safety issue with a drug and flags it for review, that decision will start a 60-day clock during which a drugmaker will have the opportunity to resolve all concerns about the product or face revocation or modifications to its market authorization. Read More

ICH Rolls Out Photosafety Testing Strategies

Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More

FDA Bans Sales of High-Strength Acetaminophen Combo Drugs

The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More