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Marketing Draft Guidance

Mintz - Health Care Viewpoints

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

King & Spalding

FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies

King & Spalding on

Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Latham & Watkins LLP

Australian Competition and Consumer Commission Adopts Tougher Stance on Greenwashing

Latham & Watkins LLP on

The ACCC sets out best marketing practices and companies’ obligations under the Australian Consumer Law, including strict penalties that may follow. In July 2023, the Australian Competition and Consumer Commission (ACCC)...more

MoFo Life Sciences

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

MoFo Life Sciences on

If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more

Vicente LLP

What Will Adult-Use Cannabis Products Look Like In New York? Draft Regulations Approved for Packaging, Labeling, Marketing and...

Vicente LLP on

What will adult-use cannabis products look like in New York? As of June 1, 2022, we can finally answer that burning question. The NY Cannabis Control Board voted yesterday to approve draft regulations for Adult-Use Packaging...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Hogan Lovells on

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

Mintz - Consumer Product Safety Viewpoints

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2016

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

King & Spalding

2014 Year in Review: OPDP Warning and Untitled Letters

King & Spalding on

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

Snell & Wilmer

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

Snell & Wilmer on

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Morgan Lewis

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

Morgan Lewis on

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

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