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Results: 1-10 of 57

U.S. Congress Reauthorizes Food and Drug Administration User Fee Programs, Acts on Other FDA Measures
  • Sidley Austin LLP
  • USA
  • August 15 2017

After more than two years of negotiations and just before the summer recess, the Senate voted to reauthorize the Food and Drug Administration's (FDA


U.S. Food and Drug Administration Announces New Tobacco Policies Acknowledging the Role of Harm Reduction
  • Sidley Austin LLP
  • USA
  • August 8 2017

On what should have been a quiet Friday in late July, the Food and Drug Administration (FDA) revealed a number of new policies, representing arguably


FDA Considers Removing Regulatory Obstacles to Generic Drug Competition
  • Sidley Austin LLP
  • USA
  • August 1 2017

On July 18, 2017, the Food and Drug Administration (FDA) held a public meeting1 to obtain input on steps it can take to encourage innovation in drug


FDA Delays Effective Date of Its Aggressive Final Rule on Intended Use
  • Sidley Austin LLP
  • USA
  • April 4 2017

On March 20, 2017, FDA announced a further delay of the effective date of its January 9, 2017, Final Rule entitled Clarification of When Products


FDA-Related Issues Not to Miss in the New Cures Legislation
  • Sidley Austin LLP
  • USA
  • January 10 2017

On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development


New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach
  • Sidley Austin LLP
  • USA
  • April 7 2016

On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products." While the


FDA Moves to Ban Powdered Gloves
  • Sidley Austin LLP
  • USA
  • March 28 2016

On March 22, the U.S. Food and Drug Administration (FDA) published a Federal Registernotice proposing to ban powdered surgeons' gloves, powdered


New Guidance Reflects Heightened FDA Focus on Medical Device Cybersecurity
  • Sidley Austin LLP
  • USA
  • January 26 2016

On January 15, 2016, the Food and Drug Administration (FDA) issued new guidance that, for the first time, recommends routine postmarketing


FDA continues scrutiny of DTC genetic testing by clinical labs
  • Sidley Austin LLP
  • USA
  • November 17 2015

The U.S. Food and Drug Administration (FDA) recently released three untitled letters from the Office of In Vitro Diagnostics and Radiological Health


FDA releases draft guidance, sets public hearing on regulation of HCTPs
  • Sidley Austin LLP
  • USA
  • November 3 2015

On October 29, the Food and Drug Administration (FDA) released a draft guidance titled “Homologous Use of Human Cells, Tissues, and Cellular and