Medical Device Legal News with Sam Bernstein: Episode 11
U.S.-licensed vaccines currently exist for hundreds of animal diseases. Among these are vaccines for diseases that affect both animals and humans, including rabies, West Nile virus, brucellosis, leptospirosis, and Lyme...more
On 18 July 2025, the European Commission (EC) published the draft guidelines on the implementation of the Foreign Subsidies Regulation (FSR Guidelines)....more
On 3 July, the CMA issued its draft guidance on the price transparency provisions in the Digital Markets, Competition and Consumers Act 2024 (DMCCA), and launched a consultation on this draft guidance (to close on 8 September...more
The Financial Conduct Authority (FCA) has published its most recent paper on non-financial misconduct (NFM), clarifying its expectations on bullying and harassment in financial services....more
On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions to the current guidance...more
FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more
CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more
On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
On April 14 2025, the European Data Protection Board (EDPB) announced the outcomes of its plenary session that took place on April 8 2025, during which the EDPB adopted draft Guidelines on processing of personal data through...more
2025 is set to be a busy year in UK consumer protection law. With the CMA issuing its annual plan for 2025 / 2026 on 27 March 2025 and its new powers to enforce consumer protection law under the Digital Markets, Competition...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
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
A few days ago, Corp Fin issued this guidance expanding the accommodations available for nonpublic review of draft registration statements to all issuers, building on the 2017 expansion of nonpublic reviews initiated by the...more
Regulation of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in soils under New York’s remedial programs was a little erratic in 2024. As to their inclusion in the New York State Department of...more
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...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
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more
Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more