We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 431

FDA issues new guidance on cGMP for combination products

  • Hogan Lovells
  • -
  • USA
  • -
  • January 23 2015

On January 23, 2015, FDA issued its long-awaited guidance document on current good manufacturing practice (cGMP) requirements for combination

FDA releases two new draft guidances aimed at mobile health

  • Hogan Lovells
  • -
  • USA
  • -
  • January 21 2015

On January 16, 2015, the Food and Drug Administration (FDA) released two draft guidances, both of which were included in the Center for Devices and

Taking another step into modern healthcare: FDA proposes rule to require electronic distribution of prescribing information for human prescription drugs

  • Hogan Lovells
  • -
  • USA
  • -
  • January 16 2015

Last month, the Food and Drug Administration (FDA) published a proposed rule, 79 Fed. Reg. 75506, requiring manufacturers to distribute prescribing

114th Congress outlook

  • Hogan Lovells
  • -
  • USA
  • -
  • January 8 2015

It is very likely that the year 2015 will see the enactment of some kind of federal tax legislation. Given the wide chasm between the goals (political

FDA announces enforcement discretion in implementing the DSCSA’s product tracing requirements, delaying enforcement until May 1, 2015

  • Hogan Lovells
  • -
  • USA
  • -
  • December 29 2014

FDA recently issued a Guidance document announcing that it will exercise its discretion not to enforce the product tracing requirements of the Drug

Latest HIPAA settlement emphasizes need to regularly address software vulnerabilities

  • Hogan Lovells
  • -
  • USA
  • -
  • December 15 2014

On December 2, the Department of Health and Human Services, Office for Civil Rights (OCR) announced a $150,000 settlement with Anchorage Community

FTC settles claims against medical billing provider for inadequate data collection disclosures

  • Hogan Lovells
  • -
  • USA
  • -
  • December 12 2014

On December 3, 2014, the Federal Trade Commission announced two administrative settlements with a medical Billing Provider, PaymentsMD, LLC, and its

NIH proposes significant expansions and modifications to requirements for clinical trial registration and results disclosure on the ClinicalTrials.gov data bank

  • Hogan Lovells
  • -
  • USA
  • -
  • November 24 2014

On Friday the National Institutes of Health (NIH) published an extensive proposed rule, intended to clarify and expand the requirements for

Expedited FDA programs for development and approval of drugs and biologics

  • Hogan Lovells
  • -
  • USA
  • -
  • November 7 2014

For sponsors developing innovative drugs and biological products, understanding the regulatory programs available to expedite development and

CMS delays Health Plan ID enforcement, giving plans more time to comply

  • Hogan Lovells
  • -
  • USA
  • -
  • November 3 2014

On October 31, 2014, the U.S. Department of Health and Human Services (HHS) announced that it would delay, until further notice, enforcement of the