Apply to the ABMS Visiting Scholars Program
ABIM
MARCH 27, 2025
The Program begins in September 2025 and concludes at the ABMS Conference in September 2026. ABMS Visiting Scholars are selected based on the quality of their proposed research project.
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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
FDA Law
SEPTEMBER 22, 2024
Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. It should be noted that 21 CFR 803.18(b)(1)(ii)
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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program
FDA Law
DECEMBER 3, 2023
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.
Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law
JULY 7, 2024
FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.
This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)
FDA Law
NOVEMBER 22, 2022
When necessary to help prevent or mitigate a foodborne illness outbreak or assist in implementing a recall, firms must generally provide an electronic sortable spreadsheet containing information that FDA requests on specified CTEs, FTL foods, date ranges, and TLCs. 7, 2022 at 1 p.m.
What RFK Jr. Isn’t Talking About: How To Make Vaccines Safer
Physician's Weekly
JUNE 26, 2025
The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. CDC vaccine safety officer Robert Chen built on VAERS to create the Vaccine Safety Datalink, which looks for evidence of vaccine harms in electronic health records. ” Asked for details, Hilliard did not respond. The current U.S.
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