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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
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
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
CDER plans to issue highly anticipated guidance in 2014 that addresses social media usage for pharma marketing and the specifics about its biosimilars approval pathway. Read More
The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Ranbaxy’s regulatory woes deepened last month as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More