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Panel OKs CDER Quality Management Maturity Program

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FDAs Pharmaceutical Science and Clinical Pharmacology Advisory Committee unanimously votes to recommend that CDER move forward wit...

MIDD Paired Meeting Updates

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FDA posts PDUFA 7 updates to the model-informed drug development paired meeting program.

GSK Stops UTI Trials and Opts for NDA

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GSK stops enrollment early due to positive results two Phase 3 trials evaluating gepotidacin, an investigational drug for uncompli...

FDA, Others Launch Global Substances System

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FDA says it is working with the National Institutes of Health and the European Medicines Agency on a global substance registration...

Califf Touts Progress in Drug Compounding Oversight

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FDA commissioner Robert Califf says FDA and its state and federal partners have made great progress in oversight of drug compoundi...

Updated Meeting Definitions

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FDA posts updated definitions of face-to-face meeting formats to the PDUFA 7 and BsUFA 3 Web pages.

Guidance on Oncology Cross-Labeling

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Federal Register notice: FDA makes available a final guidance entitled Cross Labeling Oncology Drugs in Combination Regimens.

Comments Sought on Premarket Safety Workshop

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Federal Register notice: FDA requests comments on the topics discussed at its 9/14 public workshop entitled Advancing Premarket Sa...

Draft Guide on OTC Monograph Fees

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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Over-the-Counter Monograph Dr...

Guidance on Pharmaceutical Carcinogenicity Testing

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Federal Register notice: FDA makes available a final guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Phar...