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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Tories pledge £250m each year for Pharmacy First 2027-2030

The Pharmacist

This comes on top of £20m in 2025/26 and £49m in 2026/27, as revealed by the party’s manifesto costing document, […] The post Tories pledge £250m each year for Pharmacy First 2027-2030 appeared first on The Pharmacist.

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Pharmacy Law and Licensing Highlights 2025

FDA Law Blog: Biosimilars

California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026. The most common drug Californians may be looking for this winter is Paxlovid. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

1 And we appreciated CMS’ thorough responses to comments for IPAY 2026 and hope the Agency will replicate this for this comment opportunity. The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation.

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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog: Biosimilars

Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

One of the major changes is the extension of the transition period from one to two years, with FDA now planning to enforce the QMSR requirements upon the effective date of the final rule on February 2, 2026. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.