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Federal Register notice: FDA creates a public docket to collect comments related to pediatric post-marketing pharmacovigilance and...[ Price : $8.95]
FDA says its updated analysis supports continuing to make ketoconazole 200 mg tablets available on the market for its limited indi...[ Price : $8.95]
FDA denies a United Therapeutics petition asking it to establish specific requirements for approving an ANDA for generic Tyvaso, w...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes MB Industria Cirurgica, QLRAD Netherlands, Steiner Biotechnology an...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion Warns Cipher about a professional detail aid that omits references to risk information...[ Price : $8.95]
The DC Court of Appeals backs a lower court decision that an FDA decision to approve Alkermes Aristada during a period of exclusiv...[ Price : $8.95]
AdvaMed cautions FDA not to incorporate an International Medical Device Regulators Forum document on software as a medical device ...[ Price : $8.95]
Federal Register notice: FDA determines that Janssen Research & Development Nizoral (ketoconazole) tablets, 200 milligrams (mg), w...