2BInformed: How TSCA Amendments Impact Industries and Managing the EPA’s Risk Evaluations
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Newly Amended Dual Agency Disclosure Law: Much Ado About Nothing
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)...more
As any medical product business knows, compliance with the AdvaMed Code of Ethics (the “Code”) is essential. While the Code is voluntary, many states require medical product manufacturers and companies to adopt compliance...more
A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more
The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when...more
As has been widely reported, in May 2018, a Los Angeles Superior Court judge ruled that Prop 65 warning labels are required to be placed on “ready-to-drink” coffee products. Acrylamide, a Prop 65 listed chemical that...more
Top News - FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions - On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more
One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more
Last month, the FDA finalized amendments to the Nutrition Facts labeling rules for packaged foods and dietary supplements to reflect developments in nutrition science, including new scientific information regarding the link...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more