News & Analysis as of

Off-Label Use

Womble Bond Dickinson

An Update on Medical Research and Legal Battles for Psilocybin

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Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is...more

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

Napoli Shkolnik on

Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Dechert LLP

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

Dechert LLP on

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more

Mintz - Health Care Viewpoints

Guidance from FDA Clarifies a Key Issue for Industry: Non-Promotional Presentations About Unapproved Uses of Medical Products Can...

U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more

King & Spalding

Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products

King & Spalding on

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more

Goodwin

How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on Communicating Off-Label Information

Goodwin on

On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Sheppard Mullin Richter & Hampton LLP

The Government Seeks FCA Liability for Off-Label Use of Medical Devices

The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of...more

Fox Rothschild LLP

Final FDA “Intended Use” Rule Goes Into Effect September 1, 2021

Fox Rothschild LLP on

On September 1, 2021, the Food and Drug Administration’s final “intended use” rule will go into effect. The update is meant to clarify the “intended use” regulations for pharmaceutical products and medical devices...more

Quarles & Brady LLP

FDA Approval of Pfizer Vaccine – Everything Prescribers, Pharmacies, & Vaccine Administrators Want to Know & Forgot to Ask

Quarles & Brady LLP on

The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

King & Spalding

FDA Finalizes “Intended Use” Regulations

King & Spalding on

On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more

Dechert LLP

FDA Issues Final Rule Clarifying Evidence of Off-Label Marketing

Dechert LLP on

Key Takeaways - Following more than five years of revisions and delays, the U.S. Food and Drug Administration (“FDA”) published its final “intended use” rule (the “Final Rule”) and amended its regulations describing the types...more

Foley Hoag LLP

New Intended Use Rule Finalized

Foley Hoag LLP on

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

After a long and winding road, FDA finalizes much-debated “intended use” rule

Hogan Lovells on

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

Ninth Circuit Rules False Claims Act Suit Involving Off-Label Use of Medical Devices

The United States Court of Appeals for the Ninth Circuit recently considered an Order of the Central District of California dismissing a qui tam False Claims Act (FCA) suit against a medical device manufacturer based on...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Life Sciences: What's new in France? Avastin/Lucentis case: French Competition...

Dechert LLP on

On 9 September 2020, the French Competition Authority (“FCA”) issued an infringement decision sanctioning Novartis and Roche with record fines for the pharmaceutical sector in France, totaling 444 million euros, for having...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on “Intended Use” Confirms Agency Will Rely on “Any Relevant Source” of Evidence

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations. In its current form, the regulations have created long-standing confusion as to whether mere...more

Troutman Pepper

FDA Proposes Modified “Intended Use” Regulations

Troutman Pepper on

In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more

McDermott Will & Emery

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

McDermott Will & Emery on

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more

Troutman Pepper

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

Troutman Pepper on

A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more

Faegre Drinker Biddle & Reath LLP

FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more

Buckingham, Doolittle & Burroughs, LLC

Hydroxychloroquine and Chloroquine: What We Know About Off-Label Use of Drugs and Potential Malpractice Claims in Ohio

On April 24, 2020, the FDA issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19. These side effects include serious and...more

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