News & Analysis as of

21st Century Cures Act Prescription Drugs

Alston & Bird

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

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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

Alston & Bird

Health Care Week in Review: CMS Releases Three Major Medicare Final Rules

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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

King & Spalding

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

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The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more

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

King & Spalding

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

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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

Mintz - Health Care Viewpoints

Beyond COVID: House Committee Advances Several FDA-Related Bills

On Wednesday, July 15, the House Energy and Commerce (E&C) Committee advanced several bills to the House floor that demonstrate continued interest in health policy matters other than the COVID-19 pandemic. The Fairness in...more

American Conference Institute (ACI)

[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more

McDermott Will & Emery

Special Report: FDA 2019 Year in Review

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The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

Wilson Sonsini Goodrich & Rosati

A Preliminary Evaluation of the RMAT Designation's Effect on Publicly Traded Company Stock Price

The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative medical therapies. An RMAT designation conveys significant regulatory...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

McDermott Will & Emery

Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

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In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

Butler Snow LLP

Pro Te: Solutio – Vol. 11, No. 2

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In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more

Proskauer Rose LLP

ERISA Newsletter - Second Quarter 2018

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As we head into the thick of summer, all eyes are on President Trump's nomination to the U.S. Supreme Court to replace retiring Justice Anthony Kennedy and the impact the new Justice will have on shaping the law for...more

Wilson Sonsini Goodrich & Rosati

The Regenerative Medicine Advanced Therapy (RMAT) Designation and Its Importance to New Product Development

The 21st Century Cures Act enacted the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative therapies. Qualifying for RMAT designation conveys significant...more

Holland & Knight LLP

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

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The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

Faegre Drinker Biddle & Reath LLP

In 2018 Strategic Policy Roadmap, FDA Unveils Plans for 2018 Addiction, Drug Competition and Innovation Efforts

On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more

Goodwin

American College of Rheumatology Identifies Six Factors for Future FDA Biosimilar Oversight

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In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

Mintz - Health Care Viewpoints

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Dorsey & Whitney LLP

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

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Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more

Butler Snow LLP

Pro Te: Solutio - Vol. 10 No. 2 – Spring 2017

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It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more

Holland & Knight LLP

Complicated Landscape Awaits New FDA Commissioner

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A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more

Searcy Denney Scarola Barnhart & Shipley

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

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