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Results: 11-20 of 42

Increased FDA scrutiny of pre-approval communications continued in 2012

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 5 2013

Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA's

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

FDA releases draft guidance concerning clinical trials

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 6 2012

On November 20, the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials

Second Circuit rejects FDA regulation of “off-label” promotion as misbranding in Caronia case

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 3 2012

In a widely anticipated ruling, the United States Court of Appeals for the Second Circuit this morning reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), based on alleged “off-label” promotion

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

Stem cell warning letter reflects FDA focus on medical procedures

  • Sidley Austin LLP
  • -
  • USA
  • -
  • April 9 2012

On March 13, 2012, the compliance office within the Center for Biologics Evaluation and Research (CBER) at FDA sent a Warning Letter to IntelliCell Biosciences, Inc., alleging that the firm’s IntelliCell process, based on acquiring adipose-derived stem cells and resulting in stromal vascular fraction, is a biological drug regulated under the Federal Food, Drug, and Cosmetic Act

Draft guidance on DTC ad pre-review program

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 14 2012

On March 13, FDA released a draft guidance on pre-dissemination review of direct-to-consumer (DTC) television ads for prescription drugs, implementing FDCA 503B, added by Section 901(d)(2) of the FDA Amendments Act of 2007 (FDAAA), codified at 21 U.S.C. 353b (“The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement”

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

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

FDA announces two pilot projects for improving ways to trace sources of foodborne illness; FDA will solicit stakeholder input in designing and implementing the pilots

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

On September 7, 2011, the U.S. Food and Drug Administration (FDA) announced that it is moving forward with two pilot projectsone for processed foods and the other for producedesigned to help the agency and the food industry, including farms, restaurants, and grocery stores, more rapidly and effectively trace products back to a contamination source during outbreaks of foodborne illness