Group purchasing organizations are required to provide information on business practices. The Federal Trade Commission (FTC), as part of its ongoing study of pharmacy benefit managers (PBMs) and…
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FDA Proposes Updates to Clinical Trials
The drafted guidance would modernize the trials to be more efficient and reliable. The U.S. Food and Drug Administration (FDA) has released a draft guidance that provides updated…
Read MoreTreasury Sanctions Those with Ties to Counterfeit Drug Trade
Treasury Department partnered with Mexican law enforcement to identify 17 entities. The Department of the Treasury has sanctioned 17 individuals and entities based in China and Mexico for…
Read MoreSCOTUS Revives False Claims Act Case
Returns the case to the Seventh Circuit. The justices of the Supreme Court unanimously voted to revive claims brought by whistleblowers alleging SuperValu and Safeway defrauded the federal…
Read MoreFDA Proposes Easy-to-Read Medication Guides
Agency seeks to prevent adverse drug reactions and improve health outcomes. The U.S. Food and Drug Administration (FDA) has proposed that patients be provided an easy-to-read one-page guide,…
Read MoreSenate Bill Seeks to Lower Prescription Costs
Greater transparency from pharmaceutical manufacturers is also required under the legislation. A bipartisan bill was introduced in the Senate Tuesday that would “expand the availability of low-cost generic…
Read MoreCongressional Group to Address Fentanyl Crisis
The bipartisan group is working to meet the national threat head-on. The illicit smuggling of fentanyl into the United States from Mexico is “a national crisis,” a bipartisan…
Read MoreCMS to Audit Use of Antipsychotic Medications
The agency will take steps to address inappropriate use in nursing homes. The Centers for Medicare and Medicaid Services (CMS) will begin conducting targeted audits on nursing homes…
Read MoreFDA Allows Retail Sale of Abortion Pills
Pharmacies are now allowed to apply for certification for dispense. The Food and Drug Administration (FDA) has fully approved abortion pill access through retail pharmacies for the first…
Read MoreCongress Issues Report on FDA’s Aduhelm Approval
House committees are concerned with the atypical protocol that was followed. Two House committees published a report at the end of the year highlighting the irregular means the…
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