Enforcement Relief: What New Regulatory Reforms Could Mean for Hospices
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public...more
The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more
The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. New Jersey is talking about decriminalizing marijuana. Regular readers will doubtless recall that legalization...more
LEGISLATION, REGULATIONS & STANDARDS - Proposed Amendment Would Provide Funds for FDA Oversight of CBD - Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an...more
The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more
On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more
Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred...more
On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more