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...
Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nordisks and Lillys GLP-...
Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybrid Pharma became rev...
CBER director Vinay Prasad overrules the Centers career reviewers in deciding to issue Moderna a refusal-to-file letter for its BLA for an influenza v...
