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 166

FDA finalizes expanded records access rule and issues guidance

  • Jones Day
  • -
  • USA
  • -
  • April 8 2014

On April 4, 2014, the Food and Drug Administration ("FDA") finalized an interim final rule and issued two guidance documents outlining how the agency

Pharmaceutical & medical device regulatory update, issue 3

  • Jones Day
  • -
  • USA
  • -
  • April 3 2014

According to a recent report by FDA's Center for Devices and Radiological Health ("CDRH"), the annual number of medical device recalls increased by 97

New ACA information reporting starts for employers in 2015

  • Jones Day
  • -
  • USA
  • -
  • April 2 2014

Not only did the Affordable Care Act ("ACA") create a new employer "play or pay" requirement with respect to health coverage, it also requires new

FDA proposes rule to clarify classification system for medical devices

  • Jones Day
  • -
  • USA
  • -
  • March 31 2014

On Tuesday, March 25, the U.S. Food and Drug Administration ("FDA") issued a proposed rule to clarify which medical devices are subject to class III

FDA issues draft guidance on bioavailability and bioequivalence studies submitted in NDAs or INDs

  • Jones Day
  • -
  • USA
  • -
  • March 26 2014

On March 18, FDA issued a draft guidance that provides recommendations to applicants planning to include bioavailability ("BA") or bioequivalence

Pharmaceutical & medical device regulatory update, issue 2

  • Jones Day
  • -
  • USA
  • -
  • March 25 2014

In recognition of the increasingly important role fixed-combination products play in treating cancer, cardiovascular, and infectious diseases, FDA

The Affordable Care Act: considerations for employers with unionized workers

  • Jones Day
  • -
  • USA
  • -
  • March 24 2014

The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits. In past years, the

FDA draft guidance clarifies recommendations for distribution of scientific and medical publications on off-label use

  • Jones Day
  • -
  • USA
  • -
  • March 6 2014

FDA has issued draft guidance revising its 2009 guidance on manufacturers' dissemination of "journal articles" and "scientific or medical reference

FDA draft guidance promises major changes in new chemical entity exclusivity provisions

  • Jones Day
  • -
  • USA
  • -
  • February 25 2014

In recognition of the increasingly important role fixed-combination products play in treating cancer, cardiovascular, and infectious diseases, the

CDRH releases 20142015 Strategic Priorities report

  • Jones Day
  • -
  • USA
  • -
  • February 20 2014

In early February, the Center for Devices and Radiological Health ("CDRH") released its 2014-2015 Strategic Priorities, which describe the goals that