On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more
The U.S. Food and Drug Administration (FDA or Agency) has issued draft guidance, Use of Data Monitoring Committees in Clinical Trials, that applies to sponsors of clinical trials of investigational drugs, biologics, and...more
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
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more
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
The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK
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
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
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
Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence
Last month the Department of Education (“DOE” or “Department”) released an...more
11/23/2020
/ Accounting Controls ,
Audits ,
Compliance ,
Department of Defense (DOD) ,
Department of Education ,
Department of Energy (DOE) ,
Department of Justice (DOJ) ,
Educational Institutions ,
False Claims Act (FCA) ,
FBI ,
Foreign Entities ,
Higher Education Act ,
NASA ,
National Institute of Health (NIH) ,
National Security ,
Proposed Legislation ,
Reporting 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
Liability exposure and shields for vaccine developers -
As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more
5/28/2020
/ Center for Biologics Evaluation and Research (CBER) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
Popular ,
Professional Liability ,
Vaccinations ,
Virus Testing ,
World Health Organization
The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials -
Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more
3/4/2020
/ Article III ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Rule 12(b)(1) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Motion for Summary Judgment ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Preamble ,
Public Health Service Act ,
Retroactive Application ,
Rules of Appellate Procedure ,
Standard of Review ,
Standing
The Department of Justice (DOJ) recently announced that it reached a $5,500,000 settlement with a biomedical research institute that received NIH grant funding–the Van Andel Research Institute (VARI)–to resolve allegations...more
2/26/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure To Disclose ,
False Claims Act (FCA) ,
Federal Grants ,
Foreign Investment ,
Government Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Research Funding ,
Settlement
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
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 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
On February 15, 2018, CMS released a final policy decision updating the national coverage determination (NCD) governing implantable cardioverter defibrillator (ICD) implantation for Medicare fee-for-service patients. In this...more
On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more
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
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