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Results: 11-20 of 38

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Draft guidance on DTC ad pre-review program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On March 13, FDA released a draft guidance on pre-dissemination review of direct-to-consumer (DTC) television ads for prescription drugs, implementing FDCA 503B, added by Section 901(d)(2) of the FDA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FDA issues draft guidance on medical device studies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On November 10, 2011, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents with the stated purpose of encouraging medical device research and innovation of significant risk medical devices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

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

FDA reorganization furthers pro-enforcement agenda, reflects global focus

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 18 2011

On July 13, 2011, Commissioner of Food and Drugs Dr. Margaret A. Hamburg announced a reorganization to create new “directorates” overseeing the core functions and responsibilities of the agency

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