Beverly Lorell, MD on Draft Guidance

Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more

7/9/2024 / Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials

The U.S. Food and Drug Administration (FDA or Agency) has issued draft guidance, Use of Data Monitoring Committees in Clinical Trials, that applies to sponsors of clinical trials of investigational drugs, biologics, and...more

2/21/2024 / Clinical Trials , Conflicts of Interest , Draft Guidance , Food and Drug Administration (FDA)

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

8/25/2023 / Abbreviated New Drug Application (ANDA) , Clinical Trials , Data Collection , Diversity and Inclusion Standards (D&I) , Draft Guidance , Food and Drug Administration (FDA) , License Applications , Pharmaceutical Industry , Prescription Drugs

FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more

7/3/2023 / Advertising , Direct to Consumer Sales , Draft Guidance , Final Guidance , Food and Drug Administration (FDA) , Labeling , Prescription Drugs

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more

3/8/2023 / 21st Century Cures Act , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Draft Guidance , Electronic Medical Records , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

7/27/2021 / Clinical Trials , Draft Guidance , Final Rules , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , New Guidance , Sponsors

FDA Issued Draft Objective Performance Criteria For Five Device Types

Implications for 510(k) Submissions - On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more

9/27/2019 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Safety and Performance Pathway

Beverly Lorell, MD

King & Spalding

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