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Grace Therapeutics Preparing NDA Resubmission

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Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.

FDA Updates Device READI-Home Innovation Challenge Initiative

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FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate developme...

Expand Some Islet Cell Transplantation Access: Senators

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Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type...

Data from First 100 QMSR Inspections Analyzed

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Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new ...

Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews

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FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...

Senator Seeks FDA Records on Covid Vaccine Safety Review

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Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from...

Evaluate Generic Bicalutamide Manufacturers: Petition

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A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient s...

Agency Seeks Updated Generic Accutane Labels

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FDA asks manufacturers of generic Accutane to update the drugs labeling.

FDA Backs Accelerated Pathway for UniQure Huntington's Therapy

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FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accele...

FDA, African Medicines Agency Agreement on Regulatory Harmonization

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FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the...