FDA cites Zydus Lifesciences sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficienci...
A new academic paper urges FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that moving too fast to tran...
A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramatically expand disclos...
FDA approves labeling changes removing some Boxed Warnings from six hormone replacement therapy products.
A new article in the New England Journal of Medicine warns that recent federal court rulings are transforming FDA-required drug labels into powerful w...
CBER faces mounting scrutiny after its top official, director Vinay Prasad, refused the review of Modernas flu vaccine application a move that some sa...
FDA releases the form FDA-483 with 11 observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturing facility.
FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...
