On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more
The U.S. Food and Drug Administration (FDA or Agency) has issued draft guidance, Use of Data Monitoring Committees in Clinical Trials, that applies to sponsors of clinical trials of investigational drugs, biologics, and...more
The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more
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
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The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more
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
In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more
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
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons -
On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
2/10/2020
/ Anti-Competitive ,
Biologics ,
Biosimilars ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Labeling ,
Misleading Statements ,
Prescription Drugs ,
Public Comment
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