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FDA, Others Working on Rare Disease Gene Therapies

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FDA is joining with 16 other organizations to increase effective gene therapies for rare diseases.

BIMO Inspectors Learn to Rely on Remote Assessments

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CDER Office of Compliance director Don Ashley tells the Pharmaceutical Quality Symposium that during the Covid-10 pandemic, more t...

CDRH Lists FY 2022 Proposed Guidances

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FDA publishes two lists of final and draft guidance topics for FY 2022 and a list of final guidances from four years for comment o...

Comments on Draft PD Cancer Treatment Guidance

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Five drug companies comment on an FDA draft guidance on a cancer antibody treatment dosing regimen.

Novartis Phase 3 Lung Cancer Trial Doesnt Hit Endpoints

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Novartis says further evaluation of its lung cancer treatment canakinumab is warranted even though a Phase 3 trial did not meet it...

Alternative Tools Let FDA Slash Preapproval Inspections by 55%

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CDER Office of Pharmaceutical Manufacturing Assessment director Stelios C. Tsinontides says FDAs need to conduct preapproval inspe...

Two Biological Products Reporting Exemption

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Federal Register proposed order: FDA proposes to exempt certain blood and blood components for transfusion and cell and gene thera...

WLF Asks Court to Uphold Labeling Preemption

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Washington Legal Foundation says the 9th Circuit Court of Appeals should uphold a lower court multi-district litigation decision t...

New Final Rule Expands Intended Use Definition: Attorneys

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Sidley attorneys say a new FDA final rule expands the ways the agency determines whether a consumer product is intended for drug o...

Expand Draft Guidance on BE Studies in ANDAs: AAM

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The Association for Accessible Medicines recommends broadening an FDA draft guidance on some ANDA bioequivalence studies.