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Reps Want FDA Valley Fever Workshop

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Reps. McCarthy and Schweikert encourage FDA to schedule public workshops on Valley Fever therapies and use the lessons learned to ...

FDA Extends Heron Drug Review for 3 Months

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FDA extends for three months the PDUFA goal date for a Heron Therapeutics NDA for an extended-release local anesthetic.

Appeals Court Sends Lantus Case Back to District Court

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An appeals court has sent back to a federal district court an antitrust case involving the Sanofi Lantus SoloStar insulin device i...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes one medical product company R-Garden.

FDA OTC Switch for Voltaren and Pataday Drugs

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FDA approves the switch of three prescription drugs to over-the-counter status for GlaxoSmithKlines Voltaren, Alcons Pataday twice...

FDA Clears SureMAX-X Cervical Spacer

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FDA clears an Additive Implants 510(k) for the SureMAX-X Cervical Spacer, a 3D-printed titanium spinal surgery device.

CBER Plans 21 Guidances This Year

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CBER releases a list of 21 guidances it may develop and issue in 2020.

Former Generic Drug Exec Pleads Guilty

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The Justice Department says a former senior generic drug company executive is the third person to plead guilty to participating in...

Docket Opened for Vaping Injury Reports

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Federal Register notice: FDA opens a docket to obtain information about vaping products and associated lung injuries.

Reg Review Period for Endorecherches Intrarosa

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Endorecherches Intrarosa (p...