Bryan Walsh

Oct 7, 2024 | jdsupra.com | Deborah Cho |Komal Karnik Nigam |Bryan Walsh

U.S. President Joe Biden has signed into law H.R. 9747, the “Continuing Appropriations and Extensions Act, 2025,” postponing the sunset date of the rare pediatric disease PRV program. The date by which a drug must be designated as a drug for a rare pediatric disease was changed from September 30, 2024, to December 20, 2024. The date by which such designated drug must be approved in order to receive a PRV remains September 30, 2026.

Oct 2, 2024 | jdsupra.com | Michael Druckman |Meredith Manning |Bryan Walsh

FDA’s regulations set forth criteria for determining when particular products are regulated merely as transplanted human cells or tissues subject only to the authority of Section 361 of the Public Health Service Act (PHSA) to prevent the transmission of communicable diseases. Such products, referred to as “361 HCT/Ps” or 361 products, may be sold without prior FDA review.

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.

Aug 29, 2024 | lexology.com | Philip Katz |Chuck Loughlin |Gary Veron |Komal Karnik Nigam |Ilana Kattan |Jason Conaty | +3 more

This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1] FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can...

Aug 13, 2024 | jdsupra.com | Deborah Cho |Komal Karnik Nigam |Bryan Walsh

As part of the Biosimilar User Fee Amendments of 2022 (BsUFA III) program, FDA is revisiting how best to advance the development of new biosimilar products. Currently, FDA has committed to developing guidance documents focusing on formal meetings between FDA and sponsors or applicants of BsUFA products and topics related to interchangeable biosimilar biological products.