Medical Device Legal News with Sam Bernstein: Episode 11
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
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more
On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products –...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
On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more
The FDA is catching up with the increase in demand for plant-based milks that has occurred throughout the last ten years. There is no established standard for the compositional requirements of plant-based milk alternatives...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 and highlights articles from members of AGG outside the Food and Drug Practice. ...more
On February 3, 2020, the Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued jointly a draft guidance entitled, “Promotional Labeling and Advertising...more
Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and...more
On October 17, 2018, the Food and Drug Administration published a draft guidance for industry on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” ...more
On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take...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
On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain...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
On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more
The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more
On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet platforms for advertising and promotion: Internet/Social Media Platforms:...more