2026 Manufacturing Patient-Centered Provider 
FDA Law
SEPTEMBER 20, 2021
From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.
Alabama Academy of Family Physicians
FEBRUARY 19, 2025
What Happened: Passed out of the House of Representatives HB 46 – Rural Physicians Tax Credit What’s in the Bill: HB 46 terminates the existing Rural Physician Tax Credit program in Alabama, which provided tax credits to physicians practicing in rural areas, effective December 31, 2025.
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FDA Law
JUNE 14, 2023
He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.
FDA Law
FEBRUARY 20, 2025
Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. These firings will stretch the Centers resources to take on its existing workload, let alone handle thousands of complex and innovative LDTs.
FDA Law
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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