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

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 Appointment Patient-Centered 45

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

cases in 2024-2025, H5N1 disease in humans had a high mortality rate of up to 50%. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. The Bureau of Clinical Laboratories at ADPH is also providing testing but should be prioritized for patients that are underinsured or uninsured.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. The last time CDRH was significantly resource constrained (i.e.,

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Dr. Baron spoke to specific actions sponsors can take to improve representation of women in cardiac clinical trials.

Medical 59

Medical Manufacturing Patient-Centered Provider 59