Topic: regulatory compliance
Bristol Laboratories, whose partial suspension by European regulators in 2017 led to drug shortages, has had its license restored.
Wednesday, April 24, 2019
During this webinar, PwC’s Health Research Institute will review findings from a new global survey of industry executives, and provide analysis and commentary on key drug pricing issues.
Wednesday, November 28, 2018
This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2), the pathway of choice.
No production or safety problems were found at the other 45 vaccine manufacturers in China, the country's drug regulator says.
The EMA is taking action against an Italian CDMO after inspectors found what they called major deficiencies in its production of sterile drugs.
Thursday, July 12, 2018
This webinar discusses the complexity of the regulations, hurdles they overcame, and solutions that carried them over the finish line.
The FDA has banned drugs manufactured at three facilities in India operated by Ipca Laboratories as a result of ongoing concerns.
European regulators have come down on a Danish pharma repackager that they say tried to hide violations from inspectors.
Madrid-based drugmaker Angulema has been slapped by the Spanish Agency of Medicines and Medical Devices with noncompliance in its manufacturing processes and was ordered to recall more than 400 lots of its vaccines.
Pharma companies are risking the wrath of India's drugs regulator by ignoring a demand for clinical trials of combination drugs.