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Guidance on Developing Drugs for Otitis Media

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Federal Register Notice: FDA releases a guidance, Acute Bacterial Otitis Media: Developing Drugs for Treatment.

Takeda, Lundbeck File Antidepressant NDA

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Takeda Pharmaceuticals and Lundbeck submit an NDA to FDA seeking approval for vortioxetine for treating major depressive disorder ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Andes Natural Skin Care, Arkadiy Kisin/White Forest Solutions, Canadadrugs, EMG ...

Whistleblower Center Looking for Drug, Medical Device Cases

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The Corporate Whistle Blower Center calls on people with knowledge of drug or medical device company illegal activity to come forw...

Zimmer Warning Letter on Trilogy Acetabular Manufacturing

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FDA sends Zimmer a Warning Letter over manufacturing and validation issues cited after an inspection at a manufacturing facility i...

FDA Wants CDRH 6 Suit Dismissed

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FDA asks a DC federal court to dismiss a whistleblower retaliation suit brought by six CDRH employees.

Abbott Sentenced in $1.5 Billion Plea Agreement

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A Virgina court sentences Abbott Laboratories in connection with a May guilty plea agreement that hit the company with a $1.5 bill...

Broader Role for FDA in Advancing Product Innovation: Hamburg

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FDA commissioner Margaret Hamburg says FDA needs to play a broader role in helping the scientific enterprise do a better job advan...

Mylan Sues FDA Over Generic Diovan Exclusivity

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Mylan files suit against FDA over the agencys refusal to approve its ANDA for a generic copy of Novartiss Diovan (valsartan).

Inspectors Find Quality System Problems at Oregon Aesthetic

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FDAs Seattle District Office warns Oregon Aesthetic Technologies about Quality System and other violations in its manufacturing of...