Mike Druckman

Oct 2, 2024 | lexology.com | Meredith Manning |Bryan Walsh |Mike Druckman

The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food and Drug Administration (FDA) in finding that a stem cell clinic’s stromal vascular fraction (SVF) products may be regulated by the agency as new drugs.

Jun 4, 2024 | lexology.com | Robert Church |Mike Druckman |Yetunde Fadahunsi |Bryan Walsh |Ashley Grey

The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products using “platform technologies.” In the article below, we summarize FDA’s newly-clarified criteria for a platform technology designation, what to include in submission requests, when to submit those requests, and the potential benefits of platform technology designation.

Oct 12, 2023 | lexology.com | Robert Church |Mike Druckman |Heidi Forster Gertner |Andrew Strong |Blake Wilson

On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for clinical Trials Advancing Rare disease Therapeutics (START) that will offer additional meetings with the agency to sponsors of novel drugs that aim to treat rare diseases.

Mar 28, 2023 | lexology.com | Meredith Manning |Eman Al-Hassan |Robert Church |Lowell Zeta |Mike Druckman

On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect, after the COVID-19 public health emergency (PHE) declaration expires on May 11, 2023. FDA is winding down the policies and operations that flowed from the COVID-19 pandemic and the related PHE declaration in March of 2020.

Jan 19, 2023 | lexology.com | Mike Druckman |Meredith Manning |Ashley Grey

Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision diverges from several others that reached the opposite conclusion about similar (or even the same) products – setting up an appeal by FDA.