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FDA Finalizes Guidance on Formal Meetings for OTC Monograph Drugs

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The agency posts a final guidance that provides recommendations for formal meetings between the agency and sponsors or requestors ...

FDA Updates Bioequivalence Guidance for Generic Topical Corticosteroids

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FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical ...

Hearing to Examine FDA's Role in Strengthening U.S. Drug Development

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The House Energy and Commerce Subcommittee on Health plans a hearing 7/15 to examine how FDA can help strengthen U.S. leadership i...

DTC Advertising Industry Braces for Potential End of Adequate Provision

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DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provision standard could amount to ...

Ascelia Clarifies CRL on MRI Agent After Public Release

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Ascelia Pharma pushes back against FDA's recent public release of a Complete Response Letter for its MRI contrast agent Orviglance...

GSKs Jemperli Trial Meets Endpoint in Rectal Cancer

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GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients wit...

Draft Guidance Outlines Development Standards for Psychedelic Drugs

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FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors w...

FDA Approves At-Home Dosing of Leqembi for Alzheimer's

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FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients...

Proposed Rule to Modernize Drug Manufacturing Registration

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FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distribu...

Agency Sends 3rd Complete Response on Hengrui, Elevar NDA

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FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoce...