FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Posts Pediatric Drug Post-marketing Reviews

[ Price : $8.95]

Federal Register notice: FDA creates a public docket to collect comments related to pediatric post-marketing pharmacovigilance and...

FDA Denies Public Citizen Ketoconazole Petition

[ Price : $8.95]

FDA says its updated analysis supports continuing to make ketoconazole 200 mg tablets available on the market for its limited indi...

FDA Denies Without Comment UTs Tyvaso Petition

[ Price : $8.95]

FDA denies a United Therapeutics petition asking it to establish specific requirements for approving an ANDA for generic Tyvaso, w...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes MB Industria Cirurgica, QLRAD Netherlands, Steiner Biotechnology an...

ConZip Professional Aid Omits Risk Info: FDA

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion Warns Cipher about a professional detail aid that omits references to risk information...

Appeals Court OKs Otsuka Abilify Suit Dismissal

[ 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...

AdvaMed Caution on FDA Digital Action Plan

[ Price : $8.95]

AdvaMed cautions FDA not to incorporate an International Medical Device Regulators Forum document on software as a medical device ...

Nizoral Not Withdrawn Due to Safety/Effectiveness: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Janssen Research & Development Nizoral (ketoconazole) tablets, 200 milligrams (mg), w...

FDA Re-approves Pfizers Withdrawn Mylotarg

[ Price : $8.95]

FDA approves Pfizers once-withdrawn Mylotarg (gemtuzumab ozogamicin) for treating adults with newly diagnosed acute myeloid leukem...

Guide on Medical Device Panel Meetings

[ Price : $8.95]

Federal Register notice: FDA announces the availability of a guidance entitled Procedures for Meetings of the Medical Devices Advi...