On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more
The U.S. Food and Drug Administration (FDA or Agency) has issued draft guidance, Use of Data Monitoring Committees in Clinical Trials, that applies to sponsors of clinical trials of investigational drugs, biologics, and...more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
Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...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The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more
Could Help to Streamline Development and Approval -
On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
On May 10, 2023, the Drug Enforcement Administration (DEA) extended by up to 18 months the authorization, established during the now-ended COVID-19 Public Health Emergency (PHE), for certain healthcare practitioners to...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The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more
Would Require In-Person Examination In Many Prescribing Scenarios -
Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
1/10/2023
/ Animal Testing ,
Asbestos ,
Cosmetics ,
Distributors ,
Draft Guidance ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Labeling ,
Manufacturers ,
New Regulations ,
PFAS ,
Product Recalls ,
Product Safety Labels ,
Suspensions
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
The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more
On July 14, 2022, the European Commission (“EU Commission”) published a proposal to adopt an EU-wide Regulation on standards of quality and safety for substances of human origin intended for human application...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
The Department of Health and Human Services (“HHS”) is continuing its focus on women’s health, this time through its research arm, the Agency for Healthcare Research and Quality (“AHRQ”). If the COVID-19 pandemic has shown us...more
On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...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
On June 8, 2021, four Executive Branch Departments issued reports mandated by President Biden’s February 24, 2021 Executive Order on America’s Supply Chains (the “America’s Supply Chains E.O.” or the “E.O.”). The E.O....more
6/24/2021
/ Batteries ,
Biden Administration ,
Buy American Act ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Semiconductors ,
Supply Chain ,
Supply Shortages ,
Unfair or Deceptive Trade Practices
Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P...more
FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more
There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated...more
The Biological Product Patent Transparency Act (“BPPT”) – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the...more
4/8/2021
/ Abbreviated New Drug Application (ANDA) ,
aBLA ,
Antitrust Violations ,
BPCIA ,
Consolidated Appropriations Act (CAA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Orange Book ,
Patent Trial and Appeal Board ,
Purple Book ,
Transparency
Effective March 22, 2021, USDA’s Final Rule Sets Forth Regime for Producing Hemp Products in the United States, Superseding Interim Rule -
On January 9, 2021, the U.S. Department of Agriculture (USDA) issued a final rule...more
2/3/2021
/ Biden Administration ,
Cannabidiol (CBD) oil ,
Corrective Actions ,
DEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Cultivation ,
Notice of Violation ,
USDA