In its first occasion to interpret § 353b of the Federal Food, Drug, and Cosmetic Act (FDCA), the US Court of Appeals for the Ninth Circuit relied on the “implied preemption doctrine” to affirm a district court’s case dismissal for failure to state a claim under Fed. R. Civ. P. 12(b)(6).
Commissioner of Food and Drugs Dr. Robert Califf has raised at least two major issues that he hopes to address in his current tenure.
Francis J. Serbaroli discusses additional liabilities that lawyers should be aware of when settling Medicare or Medicaid fraud cases for their clients.
The Advanced Medical Technology Association (AdvaMed) announced its revised Code of Ethics on Interactions with Health Care Professionals (2022 Code) on March 18, 2022. Notable updates to the 2022 Code provide guidance on value-based care arrangements and address the integration of medical technology across products and services. Revisions also clarify requirements and best practices related to meetings, trainings, and communications with healthcare professionals (HCP). The revised 2022 Code will take effect on June 1, 2022.
The first drug transparency law was passed nearly a decade ago in Vermont. Since then, over 20 other states have implemented their own drug price transparency requirements.
The regulations implementing the CCPA require that a business verify the identity of a consumer that submits a specific-information access request to a “reasonably high degree of certainty.”
The Financial Industry Regulatory Authority (FINRA) in November 2022 released a targeted exam letter pertaining to communications for crypto products and services.
It has been a long and heated debate as to whether NFTs and certain cryptocurrencies can be deemed as securities under applicable laws and precedents.
In a prior post, we wrote about the importance of reviewing the terms governing the sale of an NFT to determine what rights, if any, are included in the sale in order to commercially exploit the asset associated with the NFT, and the confusion that emerges in interpreting such terms through the lens of copyright law.
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