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Comments on Depressive Disorder Guidance

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Four drug companies recommend changes to an FDA draft guidance on developing drugs to treat major depressive disorder.

Markey Probes FDA in Inappropriate Fentanyl Prescribing

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Sen. Edward Markey says FDA may have ignored REMS signals of inappropriate prescribing of a specific class of fentanyl products.

API Deviations Found at Kyowa Hakko Bio

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FDA warns Japans Kyowa Hakko Bio Co. about repeat CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Microdose Radiopharm Drug Guidance

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Federal Register notice: FDA makes available a final guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical...

Guide on Chewable Tablet Quality Attributes

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Federal Register notice: FDA makes available a final guidance entitled Quality Attribute Considerations for Chewable Tablets.

FDA Extends Some EpiPen Expiration Dates

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FDA extends expiration dates on some EpiPen lots to help ease product shortage.

Congress Should Legislate on Generic Label: Editor

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JAMA deputy editor Gregory Curfman calls for congressional action to resolve the question of who a consumer can sue when injured b...

FDA Clears 2 Techlab H. Pylori Tests

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FDA clears a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pyl...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Hangzhou Karic Commodities and Kyowa Hakko Bio.

UVision60 Luminelle DTx Hysteroscopy Cleared

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FDA clears a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures.