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FDA Clears 3 Diagnostic Tests for Melinta Therapeutics Baxdela

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FDA clears three antimicrobial susceptibility tests for determining the appropriate usage of Melinta Therapeutics Baxdela (delaflo...

FDA Approves a Jannsen sNDA for Xarelto

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FDA approves a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the cont...

FDA Will Explore New Opioid Packaging: Gottlieb

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As part of the Trump Administrations national public health emergency declaration against opioid abuse, FDA commissioner Scott Got...

Comments Sought on CVM Dispute Resolution Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension about a guidance on dispute resolution procedur...

Draft Guide on Generic Drug User Fees

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FDA releases a draft guidance on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.

FDA Draft Guide on Pediatric GERD Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Pediatric Gastroesophageal Reflux Disease: Developing Drugs...

Priority Review for Abbvie Endometriosis Therapy

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FDA accepts for priority review an AbbVie NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone...

FDA Clears Butterfly Network Ultrasound-on-a-Chip

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FDA clears a Butterfly Network 510(k) for what the sponsor describes as the worlds first ultrasound-on-a-chip based imaging system...

Guidance for Using De Novo Classification Process

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FDA posts a guidance on De Novo Classification Process (Evaluation of Automatic Class III Designation) that provides recommendatio...

Guide on Sharing Patient Info Collected on Medical Devices

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FDA issues a final guidance document entitled Manufacturers Sharing Patient-Specific Information from Medical Devices with Patient...