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Quantitative Imaging Assessment in Premarket Submissions

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FDA publishes a guidance with recommendations for manufacturers on information to go in premarket submissions for radiological dev...

Alliance Supports FDA Funding Bill

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The Alliance for a Stronger FDA says it supports the FDA funding proposed by a House Agriculture Appropriations subcommittee.

Make Oral Contraceptives OTC: AMA

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The American Medical Association calls on FDA to approve a switch of hormonal oral contraceptives from prescription to over-the-co...

Generic Drug Covid-19 Successes Touted

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CDER director Patrizia Cavazzoni praises accomplishments in the generic drug program during Covid-19.

FDA Update on Heater-Cooler Devices

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FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections i...

Objectionable Conditions in 2 Clinical Trials

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FDA warns Smitha Reddy and her Poway, CA-based ACRC Studies facility about objectionable conditions in conducting two clinical inv...

Outsourcing Facility Producing Illegal Drugs: FDA

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FDA warns Deerfield Beach, FL-based Hybrid Pharma about multiple violations in its work as an outsourcing facility.

Alnylam Pharma Amyloidosis Therapy Approved

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FDA approves an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection ...

FDA Draft Trial Diversity Guidance Outlined

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Troutman Pepper attorneys discuss a new FDA draft guidance giving sponsors information on presenting diversity plans to enroll und...

FDA Makena Advisory Committee Set for Mid-October

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The presiding officer for a hearing on a CDER proposal to withdraw approval for Covis Makena says the hearing will be held 10/17-1...