HHS says CBER director Vinay Prasad will step down at the end of April.
FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to submit detailed remediation plans quickly and take a more systematic approach to correcting quality problems.
HHS says CBER director Vinay Prasad will step down at the end of April.
FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to submit detailed remediation plans quickly and take a more systematic approach to correcting quality problems.
An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who sit on agency advisory committees.
A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.
