With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC)—less than 0.3 percent on a dry weight...more
1/4/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances Act ,
Decriminalization of Marijuana ,
Dietary Supplements ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells
In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially...more
On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more
6/8/2018
/ Clinical Trials ,
FDA Approval ,
Institutional Review Board (IRB) ,
Manufacturers ,
Medical Research ,
New Legislation ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Right to Try ,
Trump Administration ,
Written Consent
On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more
6/8/2018
/ Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Drug Approvals ,
Drug Design ,
Drug Safety ,
Drug Testing ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Recruitment Incentives ,
Regulatory Reform ,
Trump Administration
Holland & Knight invites you to read our Winter 2017 Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than...more
12/12/2017
/ Anti-Bribery ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FATCA ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Investment ,
Genetic Testing ,
Innovative Technology ,
Israel ,
NHTSA ,
Parent Corporation ,
Real Estate Investments ,
Real Estate Market ,
Securities and Exchange Commission (SEC) ,
Securities Violations ,
Startups ,
Transportation Industry
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
12/12/2017
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Software ,
Patients ,
Public Comment ,
Software Developers ,
Technology Sector
Alex Azar, a former executive of Eli Lilly was nominated by President Trump today to be Secretary of the Department of Health and Human Services (HHS). Azar would replace former Secretary Tom Price who resigned amid an ethics...more
In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk...more
On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more
9/19/2017
/ Congressional Committees ,
Discussion Draft ,
Drug Approvals ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Proposed Legislation ,
Regulatory Reform
FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more
The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more
...We invite you to read our inaugural Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than 3,000 years,...more
7/21/2017
/ Blockchain ,
Commercial Insurance Policies ,
Cross-Border ,
Desalination ,
Estate Tax ,
Federal Grants ,
Foreign Investment ,
Health IT ,
Innovation ,
Israel ,
Popular ,
Real Estate Investments ,
REIT ,
Startups ,
Tax Reform ,
Technology Sector
The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more
Many states now permit the use of marijuana for medical or recreational purposes and the federal government has revised certain enforcement policies related to marijuana-related crimes.
The possession, use,...more
On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply. The Drug Quality and Security Act (the act) clarifies FDA's authority to regulate drug compounding. It also creates uniform...more
The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more
In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more
2/5/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Continuing Medical Education ,
Enforcement ,
Exclusions ,
Medicaid ,
Medical Devices ,
Medical Research ,
Medicare ,
Payment Records ,
Penalties ,
Pharmaceutical Industry ,
Physicians ,
Reporting Requirements ,
Sunshine Act ,
Vendors