2025 Manufacturing Medical Patient-Centered 
FDA Law Blog
MAY 29, 2025
Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. Applying AI models to review large amounts of data from multiple manufacturers could help FDA identify early signals related to product quality and patient safety. By Adrienne R.
FDA Law Blog
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Alabama Academy of Family Physicians
FEBRUARY 19, 2025
As the 2025 legislative session swings into full gear, the Alabama Academy of Family Physicians (AAFP) has set its sights on a cadre of pivotal bills set to shape the healthcare landscape for years to come. Chip Brown, HB 2 proposes a change to existing law regarding the consent process for medical procedures involving minors.
FDA Law Blog
JUNE 14, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.
Alabama Academy of Family Physicians
FEBRUARY 20, 2025
By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. 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.
GeriPal
OCTOBER 31, 2024
Alex 00:23 And we’re delighted to welcome Peter Chin-Hong, who is an infectious disease physician and medical educator, professor at UCSF and associate dean for regional campuses. And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath.
FDA Law Blog
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. In contrast, AMP and ACLA both asserted that the rule would harm medical care.
Expert insights. Personalized for you.
102 
Let's personalize your content