Medical Device Legal News with Sam Bernstein: Episode 11
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
The draft guidelines provide further clarification to the EDPB’s interpretation of legitimate interests, and suggest a potential divergence with the UK ICO....more
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
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
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
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
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
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
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
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
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
Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more
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
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'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
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
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
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