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Government Agencies
21st Century Cures Act Proposal Issued
The federal government's healthcare tech arm released proposed provisions of the 21st Century Cures Act and enhancements to the…
Stakeholders Provide Insight to CDER on Educational Needed in Rare Disease…
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) recently sought comments on…
FDA and HHS Need to Improve Tracking and Monitoring of IRBs
The Government Accountability Office (GAO) recently released a report, saying the United States Food and Drug Administration (FDA)…
Biden Administration Provides Update on Opioid Crisis Funding
In late September 2022, United States President Joe Biden released a statement regarding what his administration has done to help…
HHS OIG Identifies Opportunities to Strengthen NIH Grantees’ Oversight of…
In June 2022, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a new…
Biden Administration Makes Plans to Renew Cancer Moonshot
On February 2, 2022, United States President Joe Biden re-launched the Cancer Moonshot with renewed White House leadership and new…
Interim Final Rule with Request for Comments Released, Requiring More…
In mid-November 2021, several government agencies released a joint interim final rule with request for comments that requires…
OPDP To Study Promotion of Prescription Drugs at HCP Conferences
In mid-July 2021, the United States Food and Drug Administration (FDA) published a proposed collection of information in the…
Stark Law Final Rule Is Effective
Readers may remember that just one day before President Joe Biden was inaugurated as the 46th President of the United States, on…
2020 OPDP Year-in-Review
The United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER) Office of Prescription…