Beverly Lorell, MD

Beverly Lorell, MD

King & Spalding

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 FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more

7/9/2024  /  Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements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 Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all medical devices into Class I,...more

1/11/2024  /  510(k) RTA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications , Proposed Rules , World Health Organization

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

11/10/2021  /  21st Century Cures Act , Data Collection , Drug Approvals , EHR , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Pharmaceutical Industry , Prescription Drugs , Real World Evidence

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

12/14/2020  /  Clinical Trials , Coronavirus/COVID-19 , Data Integrity , Department of Justice (DOJ) , Enforcement Actions , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Fraud , Medical Devices , New Guidance , Pharmaceutical Industry

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

8/20/2020  /  Civil Monetary Penalty , Clinical Trials , Compliance , Corrective Actions , Department of Health and Human Services (HHS) , Federal Register , Food and Drug Administration (FDA) , Medical Devices , National Institute of Health (NIH) , Prescription Drugs

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

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

4/10/2019  /  Algorithms , Artificial Intelligence , Comment Period , Food and Drug Administration (FDA) , Healthcare , Healthcare Facilities , Medical Devices , Popular , Public Comment , Regulatory Agenda , Software

FDA Announces “Modernization” Reforms to Medical Device Review Process

FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process - Last week FDA released two statements announcing plans and...more

12/4/2018  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , National Evaluation System for Health Technology (NEST)

FDA Identifies Fifteen Hospitals with Failures to Comply with User Facility Requirements for Medical Device Reporting

FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R....more

12/12/2016  /  Enforcement , Food and Drug Administration (FDA) , Hospitals , Medical Devices , Popular , Reporting Requirements

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

10/27/2016  /  Adverse Events , Civil Monetary Penalty , Clinical Trials , Department of Health and Human Services (HHS) , Disclosure Requirements , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , Good Cause , Medical Devices , Penalties , Pharmaceutical Industry , Public Access Laws , Public Health Service Act
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