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Government Agencies
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…
CMS Should Improve Wage Index Adjustment for Rural Hospitals
On December 30, 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a…
CMS Prior Authorization Proposed Rule Faces Backlash, Support
In mid-December 2020, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule to address prior…
FDA Releases Draft Guidance on IND Submissions for Individualized Antisense…
Earlier this year, the United States Food and Drug Administration (FDA) issued draft guidance surrounding investigational new drug…
Industry Seeks Clarity on Interchangeability for BsUFA III
Towards the end of last year, the United States Food and Drug Administration (FDA) opened a public docket to solicit comments on…
FDA Issues Draft Guidance on Proprietary Names
The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of…
CDRH Releases List of FY 2021 Priority Guidance Documents
Recently, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced a list…
HHS Issues Policy Statements and RFI on Rulemaking and Transparency
On November 24, 2020, the Department of Health and Human Services (HHS) announced two policy statements and a request for…
Bausch Health (FKA Valeant Pharmaceuticals) Agrees to $45 Million SEC…
Earlier this year, the United States Securities and Exchange Commission (SEC) announced a settlement with Bausch Health (formerly…
CMS Releases Proposed Rule to Encourage Value-Based Arrangements
In mid-June 2020, the United States Centers for Medicare and Medicaid Services (CMS) released a proposed rule (NPRM),…