OPDP Sends Warning Letter to CytoDyn Over Promotional Video for Its IND…
On February 11, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a…
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District of Delaware Rules HRSA Exceeded Its Authority in Issuing 340B…
We have written several times on the December 2020 letter issued by the United States Department of Health and Human Services…
CMS Announces New Flexibilities to QPP and MIPS
In light of the Coronavirus (COVID-19) pandemic, the Centers for Medicare and Medicaid Services (CMS) has been implementing…
Tribal Nations Reach Multi-Million-Dollar Settlement Over Opioid Claims
Earlier this year, a handful of pharmaceutical companies reached a multi-million-dollar settlement with Tribal Nations over opioid…
DOJ and FTC Aim to Increase Merger Enforcement
In January 2022, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) Antitrust Division announced a joint…
Price Transparency: Making Things Clearer or More Confusing?
When the United States Centers for Medicare and Medicaid Services (CMS) enacted its price transparency rule on January 1, 2021,…
GAO Adds HHS to High Risk List of Agencies that Need Transformation
Earlier this year, the Government Accountability Office (GAO) issued a report that puts the Department of Health and Human…
CMS Sends Out Warning Notices for Transparency Rule Non-Compliance, But No…
On January 1, 2021, the Centers for Medicare and Medicaid Services (CMS) implemented a hospital price transparency regulation that…
Continuous Professional Development for Drug Prescribing Associated with…
In late January 2022, JAMA Network Open published an original investigation, “Cost-effectiveness and Economic Benefit of…
Industry Calls for Further Clarity and Flexibility on RWD for Regulatory…
In September 2021, the United States Food and Drug Administration (FDA) issued a draft guidance, “Real-Word Data: Assessing…