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 21

FDA proposes two groundbreaking food safety rules

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 8 2013

On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety

House drug safety hearing highlights FDA focus on product safety and supply chain obligation

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 12 2010

On March 10, 2010, Dr Joshua M Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration (FDA), presented testimony at the House of Representatives' Committee on Energy and Commerce, Subcommittee on Health hearing on drug safety

New House bill proposes FDA authority to require drug sponsors to develop companion diagnostics

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 11 2010

On May 27, 2010, Representatives Patrick Kennedy (D-RI) and Anna Eshoo (D-CA) introduced HR 5440, the Genomics and Personalized Medicine Act of 2010

FDA reopens comment period to address oversight of laboratory-developed tests

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 24 2010

Last week the U.S. Food and Drug Administration (FDA or the Agency) announced that it would reopen the comment period until September 15, 2010 to provide additional time for stakeholders to submit commentsand to update already submitted commentsregarding the Agency’s oversight of laboratory developed tests (LDTs) (75 FR 5120

FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • November 19 2010

The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first substantive guidance from FDA on this issue

Senate passes food safety legislation: food product and dietary supplement implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 7 2010

On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote

GAO report on food labeling might signal renewed FDA resistance to qualified health claimsglobal life sciences: US-FDA update

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 24 2011

On January 14, 2011, the U.S. Government Accountability Office (GAO) issued a report entitled, “Food Labeling: FDA Needs to Reassess its Approach to Protecting Consumers from False or Misleading Claims,” regarding the use of qualified health claims and structurefunction claims for food products

FDA shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 15 2011

On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types

FDA draft guidance on mobile apps signals increased regulatory oversight

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices

New draft guidance on companion diagnostics signals new responsibilities for pharma and dx companies and clinical laboratories

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 26 2011

On July 14, U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance on In Vitro Companion Diagnostic Devices