Last month, Congress enacted significant reforms to the over-the-counter (“OTC”) drug review process. The reforms, enacted as part of the “Coronavirus Aid, Relief, and Economic Security Act” (“CARES Act”), change...more
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
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On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more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Draft Guidance ,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 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
Effective upon Publication, USDA’s Interim Final Rule Sets Forth One Important Part of the Regime for Marketing Hemp Products in the United States -
This week, the U.S. Department of Agriculture (USDA) issued an interim...more
11/1/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Comment Period ,
Controlled Substances ,
DEA ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Marketing ,
Public Comment ,
Regulatory Requirements ,
State and Local Government ,
Tribal Governments ,
USDA
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 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
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