FDA Guidance Archives

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

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

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

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

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

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

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

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

USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
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USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

December 2023, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA

USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

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USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Productsstuart.mccully2024-01-09T14:36:31+00:00

USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data
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USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data

December 2023, Members-Only, Significant Update, USA

USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Datastuart.mccully2024-01-09T14:24:58+00:00

USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
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USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

2023, August 2023, Diversity, Members-Only, Moderate Update, USA

USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

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USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Productsstuart.mccully2023-09-05T11:18:16+00:00

USA | Final FDA RWE Considerations Guidance Published
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USA | Final FDA RWE Considerations Guidance Published

2023, August 2023, Members-Only, RWD to Support Reg Decisions, Significant Update, USA

USA | Final FDA RWE Considerations Guidance Published

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USA | Final FDA RWE Considerations Guidance Publishedstuart.mccully2023-09-05T10:57:56+00:00

USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
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USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

2022, Members-Only, Moderate Update, November 2022, USA

USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

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USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answersstuart.mccully2022-12-17T09:35:06+00:00

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions
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USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

2022, Medical Devices, Members-Only, Moderate Update, November 2022, USA

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

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USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissionsstuart.mccully2022-12-17T09:39:22+00:00

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

USA | Draft FDA Non-Interventional Study Guidance

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

USA | FDA Finalises Rare Diseases Considerations Guidance

USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data

USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

USA | Final FDA RWE Considerations Guidance Published

USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

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