Government in the Virtual World: A Look at Public Meetings and Hearings
On April 15, 2024, the Kentucky Board of Pharmacy (“Board”) posted a suite of proposed non-resident pharmacist rules that will require any pharmacist working in another state and who provides services on a Kentucky citizen’s...more
As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety,...more
During a public hearing in New York City on Thursday, October 18, 2018, New York State regulators, including Superintendent Maria Vullo of the New York State Department of Financial Services (“DFS”), threatened to block CVS...more
As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed...more
The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers, patients, manufacturers, wholesalers,...more
On July 18, 2018, the FDA released a Biosimilar Action Plan that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more
As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more
The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more
Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more
On March 28, 2016, a dozen members of Congress sent a letter to Sylvia Mathews Burwell, the Secretary of the Department of Health and Human Services, and Dr. Francis Collins, the Director of the National Institutes of Health...more