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  USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices

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  USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices

  2024, December 2024, Members-Only, USA
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USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices

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USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devicesstuart.mccully2025-01-02T18:04:03+00:00

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  USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice

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  USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice

  2024, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, September 2024, USA
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USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice

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USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practicestuart.mccully2024-10-06T14:58:52+00:00

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  USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care

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  USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care

  2024, August 2024, Diversity, Members-Only, Minor Update, USA
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USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care

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USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Carestuart.mccully2024-09-01T11:32:40+00:00

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  USA | FDA Finalises EHR and Medical Claims Real World Data Guidance

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  USA | FDA Finalises EHR and Medical Claims Real World Data Guidance

  2024, July 2024, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
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USA | FDA Finalises EHR and Medical Claims Real World Data Guidance

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USA | FDA Finalises EHR and Medical Claims Real World Data Guidancestuart.mccully2024-08-12T12:01:15+00:00

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  USA | FDA-NIH Draft Clinical Research Glossary

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  USA | FDA-NIH Draft Clinical Research Glossary

  2024, May 2024, Members-Only, Moderate Update, USA
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USA | FDA-NIH Draft Clinical Research Glossary

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USA | FDA-NIH Draft Clinical Research Glossarystuart.mccully2024-06-08T11:08:54+00:00

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  USA | Draft FDA Non-Interventional Study Guidance

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  USA | Draft FDA Non-Interventional Study Guidance

  March 2024, Members-Only, RWD to Support Reg Decisions, USA
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USA | Draft FDA Non-Interventional Study Guidance

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USA | Draft FDA Non-Interventional Study Guidancestuart.mccully2024-04-07T10:17:27+00:00

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  USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

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  USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

  2024, February 2024, Medical Devices, Members-Only, Moderate Update, USA
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USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

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USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devicesstuart.mccully2024-03-10T15:39:28+00:00

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  USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent

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  USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent

  2024, February 2024, Members-Only, Moderate Update, USA
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USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent

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USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consentstuart.mccully2024-03-10T15:31:54+00:00

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  USA | FDA Finalises Rare Diseases Considerations Guidance

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  USA | FDA Finalises Rare Diseases Considerations Guidance

  January 2024, Members-Only, Moderate Update, Rare Diseases, USA
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USA | FDA Finalises Rare Diseases Considerations Guidance

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USA | FDA Finalises Rare Diseases Considerations Guidancestuart.mccully2024-02-08T13:46:57+00:00

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  USA | New Draft FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

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  USA | New Draft FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

  Diversity, January 2024, Members-Only, Significant Update, USA
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USA | New Draft FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

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USA | New Draft FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Productsstuart.mccully2024-02-08T13:27:50+00:00