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, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more
On 19 November 2020, the European Court of Justice (“ECJ”) ruled on the French ban of cannabidiol (“CBD”) extracted from whole hemp plants in a case relating to the marketing and distribution of hemp oil containing CBD (case...more
12/1/2020
/ Bulgaria ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Czech Republic ,
EU ,
European Court of Justice (ECJ) ,
France ,
Hemp ,
Narcotics ,
Slovakia ,
Sweden ,
Treaty on the Functioning of the European Union (TFEU) ,
Vaping
France is finally moving forward on the medical use of cannabis. At the end of 2019, Law No. 2019-1446 indicated that French law would allow for a trial for medical use of cannabis-based products. The decree and implementing...more
Maintaining its focus on breast implant safety, on September 28, 2020, FDA announced the issuance of the final guidance, “Breast Implants— Certain Labeling Recommendations to Improve Patient Communication,” (the “2020 Final...more
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
10/5/2020
/ Canada ,
Department of Health and Human Services (HHS) ,
DSCSA ,
Executive Orders ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Pharmacies ,
Pharmacist ,
Prescription Drugs
Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more
In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
7/31/2020
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Notice of Proposed Rulemaking (NOPR) ,
Prescription Drugs ,
Public Safety ,
State Implementation Plans (SIPs) ,
Trump Administration ,
Waivers
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
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
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
1/7/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Enhanced Penalties ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory History ,
Regulatory Requirements ,
Supply Chain
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
On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more
4/10/2019
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Medical Devices ,
Popular ,
Public Comment ,
Regulatory Agenda ,
Software
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
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
1/23/2019
/ Comment Period ,
Cybersecurity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Mobile Medical Applications ,
Popular ,
PreCert Pilot Program ,
Precertification ,
Public Comment ,
Software ,
Telemedicine
On August 16, 2018, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) announced (by tweet!) that it was issuing a draft...more
Last week, the U.S. Food and Drug Administration (FDA) issued a final order classifying in vitro diagnostic (IVD) tests that utilize next generation sequencing (NGS) to profile cancer tumors into Class II (special controls)....more
In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the...more
Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more