USA Archives - Page 3 of 7

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 | 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

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

USA | The Importance of Clinical Study Transparency
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USA | The Importance of Clinical Study Transparency

December 2023, Members-Only, Minor Update, USA

USA | The Importance of Clinical Study Transparency

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USA | The Importance of Clinical Study Transparencystuart.mccully2024-01-09T15:11:07+00:00

USA | FDA Finalises Digital Health Technologies (DHT) Guidance
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USA | FDA Finalises Digital Health Technologies (DHT) Guidance

December 2023, Digital Health, Members-Only, Moderate Update, USA

USA | FDA Finalises Digital Health Technologies (DHT) Guidance

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USA | FDA Finalises Digital Health Technologies (DHT) Guidancestuart.mccully2024-01-09T14:42:08+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