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Holland & Knight's Israel Practice Newsletter - Winter 2017

Holland & Knight is a U.S.-based global law firm with a strong commitment to the state of Israel. We focus on providing guidance to Israeli investors and companies interested in doing business or making investments in the...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Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology.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

FDA Issues Guidance on Expanded Access Use of Investigational Drugs

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

Legal Landscape and Guidance for Companies Involved in Marijuana Activity

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

Drug Quality and Security Act Gives FDA Authority to Regulate Drug Compounding and Creates Uniform Federal Standards for...

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

Controversial U.S. Medical Study Raises Informed Consent Questions

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

CMS Issues Final Physician Payment Sunshine Rule

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

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