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A new academic paper urges FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that mov...[ Price : $8.95]
A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramati...[ Price : $8.95]
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 awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investi...[ Price : $8.95]
FDA approves Mercks Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph ...