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Rejection of Myopia Drug Raises Questions About Regulatory Consistency

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A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myop...

Commissioners Voucher Program Q&A Published

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FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions an...

No Informed Consent in 2 Clinical Investigations: FDA

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FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.

FDA Reports Progress in MDUFA 6 Negotiations

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FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.

Isotretinoin iPLEDGE REMS Modified

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FDA approves changes to the isotretinoin REMS to take effect in 180 days.

FDA Cites Sterile Manufacturing Failures at Texas Drug Maker

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FDA issues a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the compa...

FDA Accepts Takedas Oveporexton NDA for Narcolepsy Type 1

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FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type...

FDA Refuses Filing of Moderna BLA for Flu Vaccine

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FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the co...

FDA Hits Sobis Vonjo TV Ad as Misleading

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FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (...

Repeat CGMP Violations at Signature Formulations

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FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contra...