Deborah Cho

Jan 17, 2025 | jdsupra.com | Deborah Cho |David Fox |Komal Karnik Nigam

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act” that is scheduled for May 15, 2025.  FDA seeks input from patient/parent/caregiver groups, consumer groups, industry, academia, and other interested parties on topics related to pediatric drug development and labeling.

Nov 14, 2024 | jdsupra.com | Deborah Cho |Jason Conaty

FDA recently announced final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” as well as Q&A guidance of the same name, which provides recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms that are designed to deliver drugs to systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

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.

Aug 30, 2024 | jdsupra.com | Deborah Cho |Jason Conaty |Komal Karnik Nigam

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] Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can be expected to produce the same clinical result as the reference product in any given patient.”[2] For a...

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...