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Clinical Pharmacology Considerations for Antibody-Drug Conjugates

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FDA posts a draft guidance on antibody-drug conjugate clinical pharmacology considerations.

FDAs Pazdur Red Flags China-based Oncology Programs

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Writing in the 2/4 The Lancet, FDA Oncology Center of Excellence director Richard Pazdur calls into question the development of do...

GAO Report Looks at Unannounced Foreign Inspections

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A just-released Government Accountability Office report offers recommendations on an FDA-planned pilot program to test unannounced...

Comments Extended on Device Discontinuance Notice

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Federal Register notice: FDA extends the comment period for a 1/11 notice about a draft guidance entitled Notifying the Food and D...

Guide on OTC Drug Monograph Formal Meetings

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Federal Register notice: FDA posts a draft guidance on over-the-counter monograph drug formal meetings between the agency and spon...

FDA Warning on E25Bio Covid Tests

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FDA issues a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test due to concerns about false results.

FDA Green Lights Domestic Inspections Beginning 2/7

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FDA removes its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 now that Covid-19 cases ...

Wells Pharma Hit With 483 After Inspection

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FDA issues Wells Pharma (Houston, TX) a one-item Form FDA-483 after a 6/2021 inspection at the drug outsourcing facility.

Guide on Mitigating Primate Supply Contraints

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FDA releases a final guidance entitled Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from ...

Immunogenicity Drug Labeling Guidance

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Federal Register notice: FDA makes available a draft guidance entitled Immunogenicity Information in Human Prescription Therapeuti...