Latest Publications

Share:

FDA Issues Guidance for Diagnostic Testing Applicable to Coronavirus Disease

The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more

President Trump's Budget Seeks FDA Resources for CBD Enforcement | Insights

In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug...more

FDA Issues New Warnings and Raises Questions About Use of CBD

On November 25, 2019, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to several companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised...more

USDA Releases Interim Final Rule for Industrial Hemp Production, Requests Comments

The U.S. Department of Agriculture (USDA) has issued an Interim Final Rule (IFR) for the establishment of a domestic hemp production program. By publishing the rule in the form of an IFR, USDA is able to issue guidance before...more

FDA Publishes Consumer Update on Cannabis Products, Including CBD

On June 14, 2019, the FDA published a Consumer Update entitled "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD." In the Update,...more

FDA Considering Changes to Regulation of CBD Products - Agency Holds Public Hearing on Cannabis to Gather Input from Stakeholders,...

• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed. • The...more

FDA Issues Statement on Cannabis Regulation and Announces Public Hearing

On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more

FDA Open to “Alternative Approaches” to Regulating CBD

FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products. The announcement came as Commissioner Scott Gottlieb spoke on the...more

Government Re-Opens: Impact on FDA

The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back...more

FDA Announces New Policies to Advance Cell and Gene Therapies

On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more

The Government Shutdown and Its Effects on the FDA

Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more

Hemp is Now Legal, But What Does That Actually Mean?

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

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

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

FDA Commissioner Speaks Out on Compliance and Enforcement

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

FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

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

Right to Try Law Enacted by Congress: Implementation Unclear

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

FDA Announces Modernization of Drug Review Process and Operations

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

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

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

Former Pharmaceutical Company Executive Picked to Run HHS

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

Digital Health: FDA Announces New Policy for Genetic Testing Regulation

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

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

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

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

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

New FDA Digital Health Program

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

Holland & Knight's Inaugural Israel Practice Newsletter - July 2017

...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

55 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide