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3 Stakeholder Comments on FDA QTc Guidance

[ Price : $8.95]

PhRMA suggests that FDA revise a draft guidance on QTc labeling to incorporate an International Council on Harmonization guideline...

Lilly Plans 2024 BLA for Crohns Drug

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Reporting positive data from a Phase 3 study on mirikizumab in Crohns disease, Eli Lilly says it will seek FDA approval for the dr...

14 House Dems Want ADHD Drug Shortage Info

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Rep. Abigail Spanberger and 14 Democratic colleagues ask FDA and DEA for more information on their work to resolve shortages of AD...

FDA Lifts Hold on PepGen Study

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FDA lifts a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patie...

Fast Track for Glioblastoma Vaccine

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FDA grants MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastom...

FDA Sets Digital Health Technologies A/C

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FDA says it will accept until 12/11 applications for its new Digital Health Technologies Advisory Committee.

Info Collection on Radiopharmaceuticals

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Federal Register notice: FDA seeks comments on an information collection entitled Regulations for In Vivo Radiopharmaceuticals Use...

Cell, Gene Therapy Success Rates Analyzed

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A Tufts Center for Biomedical System Design analysis says cell and gene therapies are more likely to be successful than other ther...

Breakthrough Devices Could Aid Disadvantaged: Attorneys

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Two Reed Smith attorneys explain how FDA may grant a breakthrough device designation to medical devices that have the potential to...

Senator Calls on FDA to Probe Respironics

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Sen. Richard Blumenthal (D-CT), in a second complaint, urges FDA to join the U.S. Department of Justice to thoroughly investigate ...