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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

It then establishes a new Rural Physician Income Tax Credit program, effective January 1, 2026, that provides a $10,000 annual tax credit to qualifying rural physicians for up to four tax years. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

Insurance 130

Insurance Management Hospital Vaccination 130

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.

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45

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.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98