The FDA Law Blog
SEPTEMBER 16, 2024
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.
The FDA Law Blog
FEBRUARY 2, 2025
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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PQA
APRIL 26, 2023
PQA has a new frequently asked questions (FAQ) document that addresses background and basics of SDS risk adjustment and PQA’s risk adjustment recommendations for the three adherence measures in Medicare Part D (PDC-Diabetes All Class, PDC-Renin Angiotensin System Antagonists, and PDC-Statins).
The FDA Law Blog
FEBRUARY 21, 2024
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.
DiversifyRx
JULY 11, 2024
The exemption will last until November 27, 2026, for those small dispensers who qualify. To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request.
pharmaphorum
SEPTEMBER 23, 2022
It was already unlikely that the two companies would get a positive outcome from the Oncologic Drugs Advisory Committee (ODAC), after damning assessments by the FDA reviewer in documents published ahead of yesterday’s decisions, but shares in both firms still slumped after the verdicts emerged.
PQA
NOVEMBER 20, 2023
Ultimately, these measures aim to reduce the use of these combinations of medications in the older adult population, for which serious safety concerns have been documented. Continued support and use of the POLY-ACH and POLY-CNS measures has grown over the years since their endorsement by PQA’s membership in 2017.
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