Industry Seeks Power To Trigger Safety Labeling Changes Under FDAAA
Seeking to turn the regulatory burdens imposed by the FDA Amendments Act to their advantage, pharmaceutical manufacturers are asking the agency to give sponsors the power to trigger safety-related labeling changes under the statute.
More from Archive
More from Pink Sheet
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.