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Pallone Asks GAO to Analyze RIF Impact on User Fees

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House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid...

Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust

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A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory co...

Full Approval Given to Lilly's Retevmo

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FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pe...

CGMP Issues Found at International Medication Systems

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FDA warns South El Monte, CA-based International Medication Systems about CGMP violations in its production of finished drugs.

Multiple Violations in ZIIP Inspection

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FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adulterated and misbranded unappr...

Biogen Defends Anti-Tau Alzheimer's Data After Investor Selloff

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Biogen executives attempt to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promi...

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Draft Guidance Outlines Development Standards for Psychedelic Drugs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FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors w...