2025 Biosimilars Pharmacy 
Drug Channels
JUNE 25, 2024
Attendance will be limited, so click here to request an invite for our March 2025 event. Happy 248th birthday, America! Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.
FDA Law Blog: Biosimilars
NOVEMBER 11, 2024
Comments on the proposed order are due May 25, 2025. Whether those products will be reformulated to include pseudoephedrine and then held behind-the-counter is unknown but seems unlikely as well as unwelcome from the standpoint of pharmacy management. That means almost certainly no sooner than the second half of 2026.
FDA Law Blog: Biosimilars
DECEMBER 3, 2023
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. Final Guidance at 2. 1395w-114c(b)(4)(B)(i).
Agency IQ
OCTOBER 27, 2023
WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. What ever happened to that thing?
Agency IQ
FEBRUARY 15, 2024
In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.
Drug Channels
NOVEMBER 12, 2024
president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. Fein, Ph.D., to 1:30 p.m. Or, just click here to order.)
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