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HHS OIG Finalizes New Exclusion Rules as Administration Exits
  • Hogan Lovells
  • USA
  • January 13 2017

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General


NRC revising two guidance documents impacting medical use licensees; requests public comment
  • Hogan Lovells
  • USA
  • January 13 2017

The U.S. Nuclear Regulatory Commission (NRC) recently published two draft guidance documents for public comment that impact users of radioactive


340B Program: HRSA Releases Ceiling Price and CMP Final Rule
  • Hogan Lovells
  • USA
  • January 9 2017

Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of


FDA Clarifies Requirements Regarding Submission of Manufacturing Establishment Information
  • Hogan Lovells
  • USA
  • January 6 2017

On December 29, 2016, FDA issued a new draft guidance regarding drugs and biologics entitled “Providing Regulatory Submissions in Electronic


On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance
  • Hogan Lovells
  • USA
  • January 4 2017

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories -


The More the Merrier: Knowing When, Why, and What to Tell FDA about Combination Product Postmarket Events
  • Hogan Lovells
  • USA
  • December 21 2016

The US Food and Drug Administration (FDA) announced on December 20, 2016 that it is issuing final regulations governing postmarketing safety


President Obama Signs 21st Century Cures Act into Law, Exempting Certain Types of Medical Software from FDA Regulation
  • Hogan Lovells
  • USA
  • December 16 2016

On Tuesday, December 13, President Obama signed into law the 21st Century Cures Act. That Act previously passed both houses of Congress with


Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act
  • Hogan Lovells
  • USA
  • December 16 2016

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60


Much to Metabolize: The 21st Century Cures Act Introduces Numerous Changes to FDA’s Drug Regulatory Framework to Spur Development of New Treatments
  • Hogan Lovells
  • USA
  • December 14 2016

With President Obama's signature, the 21st Century Cures Act (Cures Act) has become law, unleashing an expansive suite of measures designed to


Are Your Reasonable Assumptions Ready for Their Close-Up? The OIG's 2017 Work Plan and Focus on Drug Pricing and Reimbursement
  • Hogan Lovells
  • USA
  • December 14 2016

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) releases an annual Work Plan that details where it will focus its