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Results:1-10 of 3,399

OIG Dusts off the Old Rule Book to Say No to Free Expensive Drugs to Hospitals
  • McDermott Will & Emery
  • USA
  • December 10 2018

The Office of Inspector General, Department of Health and Human Services posted an unusual negative Advisory Opinion (AO 18-14) on a drug company’s


FDA Reexamining Communication Practices with Investigational New Drug Sponsors
  • Epstein Becker Green
  • USA
  • December 6 2018

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess


OIG Considers Drug Pricing History in an Unfavorable Advisory Opinion on Free Drugs
  • Holland & Knight LLP
  • USA
  • November 27 2018

The OIG issued an unfavorable Advisory Opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an


FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies
  • Epstein Becker Green
  • USA
  • November 20 2018

Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to


CMS considers linking Medicare drug payment rates to international prices
  • Hogan Lovells
  • USA
  • October 30 2018

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential


HHS Proposes Disclosure of Drug Prices in TV Advertising, But Fight Over Authority On the Horizon
  • Arent Fox LLP
  • USA
  • October 29 2018

The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or


BakerHostetler FDA and Pharmacy Weekly Digest - October 29, 2018
  • Baker & Hostetler LLP
  • USA
  • October 29 2018

The Food and Drug Administration (FDA) announced that it is investigating a multistate outbreak of Salmonella enteritidis it believes is linked to


Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
  • Seyfarth Shaw LLP
  • USA
  • October 24 2018

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs


FDA schedules public hearing on solutions to drug shortages
  • Hogan Lovells
  • USA
  • October 8 2018

FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a


CMS Allows Medicare Part D Indication-Based Formulary Design
  • Holland & Knight LLP
  • USA
  • August 30 2018

The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D