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.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 34

Decoding FDA: five things to know about the FDA’s June 6 response to the MIWG citizen petition concerning off-label promotion
  • Sidley Austin LLP
  • USA
  • June 18 2014

On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical


FDA proposes two safety rules governing imported foods
  • Sidley Austin LLP
  • USA
  • July 31 2013

On July 29, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") published two significant, long-awaited proposed rules mandated by


FDA moves forward with program for Medical Device Development Tools
  • Sidley Austin LLP
  • USA
  • September 8 2014

On August 15, 2014, FDA announced that it is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDTs


FDA issues warning letter to Lancôme for anti-aging claims
  • Sidley Austin LLP
  • USA
  • September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics


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FDA issues draft guidance on medical device studies
  • Sidley Austin LLP
  • USA
  • November 18 2011

On November 10, 2011, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents with the stated purpose of encouraging medical device research and innovation of significant risk medical devices


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 request for comments on timing for implementation of safety labeling changes
  • Sidley Austin LLP
  • USA
  • January 4 2012

On December 20, 2011, the U.S. Food and Drug Administration (FDA) published a notice requesting public input on the deadlines for implementing drug safety labeling changes


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