The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more
The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more
The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more
1/19/2023
/ Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
New Regulations ,
Personal Care Products ,
Product Labels ,
Product Safety Labels ,
Proposed Legislation ,
Registration Requirement ,
Regulatory Oversight ,
Reporting Requirements
In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more
1/13/2023
/ Abortion ,
Biden Administration ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Policy Statement ,
Pregnancy ,
Reproductive Healthcare Issues ,
State and Local Government
Last week, the Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or...more
Key Takeaways:
The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials.
FDA’s recommendations come as part of increasing interest in ensuring clinical...more
4/20/2022
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Biologics ,
Black and Minority Ethnic (BME) ,
Clinical Trials ,
Corporate Counsel ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
FDASIA ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Licenses ,
National Institute of Health (NIH) ,
Premarket Approval Applications ,
Sponsors
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
Key Takeaways:
▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more
2/14/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Standards ,
Supply Chain ,
Third-Party
Earlier this week, the Food and Drug Administration released the latest in a series of draft guidance documents on the topic of real-world data (RWD) to support regulatory decision-making for drugs and biological products....more
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more
10/29/2021
/ Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Canada ,
Healthcare ,
International Medical Device Regulators Forum (IMDRF) ,
Machine Learning ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
Regulatory Oversight ,
Technology Sector
The Food and Drug Administration (FDA) updated a final guidance and a companion draft guidance (the “first draft guidance”) providing answers to questions related to the agency’s regulation of biosimilar products and its...more
The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more
9/20/2021
/ Cannabis Products ,
Centers for Disease Control and Prevention (CDC) ,
Drug Safety ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hemp ,
Life Sciences ,
Misbranding ,
Public Health ,
Risk Factors ,
THC
The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and...more
9/10/2021
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Comment Period ,
Department of Agriculture ,
Federal Meat Inspection Act (FMIA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Labeling ,
Meat Processing Plants ,
Poultry Products Inspection Act (PPIA). ,
Public Comment ,
USDA
More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more
On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more
8/6/2021
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Intended Use ,
Manufacturers ,
Off-Label Use ,
Pharmaceutical Industry ,
Product Labels ,
Regulatory Oversight
President Donald Trump signed an Executive Order (EO) on Thursday, August 6, 2020 directing federal agencies to “Buy American” when purchasing “essential” drugs, medical supplies and equipment rather than purchase these...more
8/7/2020
/ Buy American Act ,
Environmental Protection Agency (EPA) ,
Essential Goods ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Equipment ,
Medical Supplies ,
OMB ,
Prescription Drugs ,
Trump Administration ,
United States
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
On May 11, the U.S. Food and Drug Administration (FDA) released two guidance documents to provide recommendations for sponsors “to accelerate development” of drugs and biologics designed to prevent or treat COVID-19. ...more
On Friday, April 10, 2020, the Food and Drug Administration (FDA) announced that it has issued two additional Emergency Use Authorizations (EUA) in response to the coronavirus pandemic: one for a device that is used to...more