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
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On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
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Draft Guidance ,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
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
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
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
Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more
3/10/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances Act ,
Decriminalization of Marijuana ,
Enforcement Actions ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Public Hearing ,
Regulatory Oversight ,
Risk Management
On January 15, 2020, the House Energy & Commerce Committee, Subcommittee on Health held a hearing entitled “Cannabis Policies for the New Decade.”
Government witnesses testified from:
• the Drug Enforcement...more
1/17/2020
/ Cannabidiol (CBD) oil ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Dietary Supplements ,
Expungement ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Marijuana-Infused Edibles ,
Medical Marijuana ,
National Institute of Health (NIH) ,
Regulatory Agenda ,
Research and Development ,
Schedule I Drugs
Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more
Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds -
On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more
4/8/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Enforcement ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Related Businesses ,
Public Comment ,
Public Health ,
Public Meetings ,
Public Notice ,
Regulatory Agenda ,
Regulatory Authority ,
Warning Letters
Failure To Maintain Listings May Affect Operations and Coverage for Reimbursement –
The Federal Food, Drug, and Cosmetic Act (“FDCA”) has long required pharmaceutical manufacturers, repackers, relabelers, and salvagers to...more
Would Not Require Collaboration by the Drug Sponsor; FDA Requests Comments on Potential Approach -
The Food and Drug Administration (FDA) requests comment on a potential approval pathway for “ devices referencing drugs”...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