News & Analysis as of

Food and Drug Administration (FDA) 21st Century Cures Act

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

Alston & Bird

Health Care Week in Review: Congress Passed a New Continuing Resolution for FY 2024 to Avert a Government Shutdown; Biden...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Gardner Law

What Does FDA Think of AI?

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Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more

Health Care Compliance Association (HCCA)

FDA Consolidates, Revises Informed Consent Guidance; 2018 Common Rule Not Addressed

Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

Mintz - Health Care Viewpoints

The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?

The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their...more

King & Spalding

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

King & Spalding on

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more

Harris Beach PLLC

There’s an app for that! But is your health care app in compliance?

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The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more

King & Spalding

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

King & Spalding on

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Clinical Decision Support (CDS) Software Guidance

In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more

King & Spalding

FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News

King & Spalding on

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more

Mintz - Health Care Viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 10. In This Month’s E-News: October 2022

Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Mintz - Health Care Viewpoints

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more

Foley & Lardner LLP

FDA Issues Latest Draft Guidance on the Use of Real-World Data and Evidence to Support Regulatory Decision-Making for Drug and...

Foley & Lardner LLP on

On December 8, 2021 and in response to the mandate under the 21st Century Cures Act to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, the U.S. Food and Drug Administration (FDA) released...more

Foley Hoag LLP

FDA Releases the Latest in a Series of Draft Guidance Documents on Real World Data

Foley Hoag LLP on

Earlier this week, the Food and Drug Administration released the latest in a series of draft guidance documents on the topic of real-world data (RWD) to support regulatory decision-making for drugs and biological products....more

MoFo Life Sciences

Rescinding The MCIT/R&N Final Rule, CMS Seeks New Approaches For Innovative Technology Coverage

MoFo Life Sciences on

On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As...more

Faegre Drinker Biddle & Reath LLP

Global Pandemic Accelerates Trend Toward Use of Real-World Data Sources

The global pandemic has accelerated the Food and Drug Administration’s (FDA) encouragement of real-world data (RWD) and real-world evidence (RWE) (the clinical evidence derived from analysis of RWD), particularly as the FDA...more

Goodwin

Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation

Goodwin on

Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more

King & Spalding

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

King & Spalding on

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

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Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more

MoFo Life Sciences

CURES 2.0: WILL IT BE BETTER THAN THE ORIGINAL?

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It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of...more

Akin Gump Strauss Hauer & Feld LLP

Cures 2.0, A Deeper Dive on ARPA-H and MCIT as Congress Considers Accelerating Innovation from Bench to Bedside

Background on Cures 2.0 - The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more

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