2025 Clinic Manufacturing Screening 
Alabama Academy of Family Physicians
MAY 15, 2025
The 2025 Alabama Legislative Session concluded on May 14 at midnight. Bill Easing Volunteer Rules for Retired Physicians Awaits Governor’s Signature What’s in the Bill: HB 346 streamlines volunteer opportunities for retired physicians at free health clinics is headed to the Governor for final approval.
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
APRIL 7, 2025
Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.
Alabama Academy of Family Physicians
FEBRUARY 20, 2025
Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. 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.
FDA Law Blog
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.
Expert insights. Personalized for you.
130 
Let's personalize your content