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The Department of Justice (DOJ) wants to see that when it settles a fraud case with a drugmaker the company does not slip back to its old, bad habits once the prosecutors leave, and it’s increasingly using corporate integrity agreements to make that happen. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More
Federal prosecutors indicated Thursday they view Physician Payment Sunshine Act reports as a potential source of data to build new False Claims Act investigations. Read More
Drugmakers’ validation activities should be clearly defined in a validation master plan (VMP) that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
FDA Commissioner Margaret Hamburg took the unusual step Thursday of publicly defending the agency’s expedited drug approval pathways in the face of growing criticisms, which now include a congressional inquiry into the FDA’s approval standards. Read More
To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file. Read More
Sponsors of new drugs and biologics intended to treat chronic pain should plan on submitting more safety data than they would to support candidates for acute pain, the FDA says. Read More