Podcast: Non-binding Guidance: Breakthrough Devices Program
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more
On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more
The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”)...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
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. This week's topics include: ...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
Recently the United States Patent and Trademark Office (USPTO) announced a new prioritized examination program for trademark and service mark applications meeting certain requirements. The program allows applicants to...more
Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new authorities that will...more
On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for Over-the-Counter (OTC) drugs. ...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
Last week, the World Health Organization (WHO) announced that it signed a memorandum of understanding with the International Generic and Biosimilar Medicines Association (IGBA) to promote access to generics and biosimilars. ...more
Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham,...more
Faulty Implants Cause Pain, Problems and Peril - Did you know that arthritis is the leading cause of disability for adults in the U.S.? By 2030, American citizens over the age of 65 will outnumber children for the first...more
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more