FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an inspection last month.
A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.
FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an inspection last month.
A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.
HHS says CBER director Vinay Prasad will step down at the end of April.
An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who sit on agency advisory committees.
