Could Simplified Clinical Trials Lead to More Diversity?
During comments made at the 2023 Innovations in Regulatory Science Summit, Food and Drug Administration (FDA) Center for Drug…
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GoodRx Fined in First Violation of the Health Breach Notification Rule
The United States Federal Trade Commission (FTC) filed a proposed order with the Department of Justice (DOJ) regarding GoodRx…
Walgreens to Pay $83 Million in West Virginia Opioid Settlement
West Virginia and Walgreens reached an $83 million settlement, resolving claims over Walgreens’ role in perpetuating the opioid…
Pfizer Loses Anti-Kickback Case at SCOTUS
We previously wrote about the petition Pfizer filed at the Supreme Court of the United States (SCOTUS), seeking the reversal of a…
Pharmaceutical Industry Sees a Win in 340B Fight
In a win for the pharmaceutical industry, the United States Court of Appeals for the Third Circuit recently ruled that the…
DOJ and HHS OIG Commit to Working Together to Protect Health Care Markets
Recently, the Antitrust Division of the Department of Justice and the Department of Health and Human Services Office of the…
HHS Issues Proposed Rule to Modify ADR Process
Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US…
CMS Releases Proposal to Streamline Medicare Advantage and Part D
On December 14, 2022, the Biden administration released a proposal to streamline Medicare Advantage (MA) and Part D plan prior…
CMS Issues New Prior Authorization Rule
CMS has issued a new rule meant to streamline prior authorization by requiring certain payers to implement an electronic prior…
DOJ Announces Increased False Claims Act Penalties as a Result of Inflation
The Department of Justice has announced inflationary adjustments to the False Claims Act’s civil monetary penalties as a result of…