Agency IQ

AUGUST 16, 2024

Areas of expertise included psychiatry, post-traumatic stress disorder, emergency medicine, pharmacy and medication safety, and statistics. The study is planned to begin in 2026 and conclude in 2028. The meeting’s roster included five voting members from PDAC, six temporary voting members, and one non-voting industry representative.

FDA 40

FDA Trials Therapies Regulations 40

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. The pharmacy prompt payment requirements from the CGDP will also apply to the Discount Program. 1395w-114c(b)(4)(B)(i).

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Compliance Drugs Pharmacy Licensing 105

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection.

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FDA Science Biosimilars Clinical Trials 40

Drug Channels

APRIL 24, 2025

After a blockbuster inaugural event and tremendous feedback from attendees, were excited to announce that the Drug Channels Leadership Forum (DCLF) returns on March 1618, 2026 , at the Turnberry Resort & Spa in Miami. Join us at DCLF 2026 Invitations will begin going out in October 2025. GET STARTED Be part of the conversation!

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Pharmacy Testimonials Drugs Pharmaceuticals 52

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.

Licensing 59

Licensing Licensing Pharmacy Packaging 59

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. 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.

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FDA Production Pharmacy International 111