2026 Clinic IT Manufacturing 
FDA Law Blog
SEPTEMBER 20, 2021
The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. In response, FDA memorialized its intention to use some of the new tools explored during the pandemic and potentially make them more permanent fixtures of facility inspections (e.g.,
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
JUNE 14, 2023
Shuren stated that some of the manufacturers of these devices have already experienced more interactions in the past few weeks than they otherwise would have over the entire development course of their devices. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).
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. Mullen & Jeffrey N. It did not.
FDA Law Blog
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. Last Thursday, the U.S.
Expert insights. Personalized for you.
52 
Let's personalize your content