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Pharmaceutical Industry › Food and Drug Administration (FDA) › Mobile Health Apps

Hogan Lovells

Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk

Hogan Lovells on

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS...more

Faegre Drinker Biddle & Reath LLP

Patient Perspectives—There’s an App for That!

Faegre Drinker Biddle & Reath LLP on

On November 7, the U.S. Food and Drug Administration (FDA) announced the launch of the MyStudies app, the latest in a series of concrete activities to drive the integration of the patient voice in clinical trials and the drug...more

McGuireWoods LLP

Big Brother is a Pill: Digital Tracking Drugs

McGuireWoods LLP on

Drug adherence programs have significantly evolved over the last few years with drug companies, health plans, and providers taking steps to monitor patient medication compliance. Drug adherence is the degree to which a...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

Mintz - Health Care Viewpoints on

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2017

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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