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FDA approves labeling changes removing some Boxed Warnings from six hormone replacement therapy products.[ Price : $8.95]
A new article in the New England Journal of Medicine warns that recent federal court rulings are transforming FDA-required drug la...[ Price : $8.95]
CBER faces mounting scrutiny after its top official, director Vinay Prasad, refused the review of Modernas flu vaccine application...[ Price : $8.95]
FDA releases the form FDA-483 with 11 observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturin...[ Price : $8.95]
FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions o...[ Price : $8.95]
Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nord...[ Price : $8.95]
Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybr...[ Price : $8.95]
CBER director Vinay Prasad overrules the Centers career reviewers in deciding to issue Moderna a refusal-to-file letter for its BL...