Remove Management Remove Manufacturing Remove Patient-Centered Remove Utilities
article thumbnail

Interdisciplinary Case Report

CDOCS

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

article thumbnail

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry.

IT 69
article thumbnail

Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

The bill also requires the Alabama Statewide Area Health Education Center Program Office to administer and verify the eligibility of physicians claiming the credit and mandates an evaluation of the program’s success during the 2030 fiscal year. SB 93 – PBM Bill What’s in the Bill : SB 93 , sponsored by Sen.

Insurance 130
article thumbnail

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

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.