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Results: 1-10 of 171

HHS issues proposed rule that would revise the Federal Policy for the Protection of Human Subjects
  • King & Spalding LLP
  • USA
  • September 28 2015

On September 8, 2015, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies collectively issued in the


Food safety and recalls a global challenge: manufacturers can reap long-term benefits from short-term compliance adjustments
  • King & Spalding LLP
  • USA
  • July 31 2015

MCC interviews Smitha G. Stansbury, a partner in the FDA and Life Sciences practice group of King & Spalding, resident in the firm's Washington, D.C


FDA announced a four-month enforcement delay on certain Drug Supply Chain Security Act product tracing requirements for dispensers
  • King & Spalding LLP
  • USA
  • July 1 2015

FDA Does Not Intend to Enforce Product Tracing Requirements Related to Dispensers' Receipt and Maintenance of Product Tracing Information Until


FDA initiates Expedited Access Pathway program for medical devices via final guidance document
  • King & Spalding LLP
  • USA
  • May 11 2015

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical


CMS issues guidance on reimbursement for biosimilars under Medicare and Medicaid
  • King & Spalding LLP
  • USA
  • April 15 2015

On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare &


First Circuit finds federal preemption of state tort claims that conflict with a medication’s FDA-approved labeling & warnings
  • King & Spalding LLP
  • USA
  • March 2 2015

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act ("FDCA"


Free speech & pharmaceutical promotion U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.
  • King & Spalding LLP
  • USA
  • February 23 2015

Off-label prescription drug use using drugs to treat ailments not indicated on FDA-approved labeling is among the thorniest legal


FDA revises approach to presentation of risk information in brief summary
  • King & Spalding LLP
  • USA
  • February 10 2015

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for


FDA simplifying physician application process for compassionate use of unapproved drugs
  • King & Spalding LLP
  • USA
  • February 9 2015

On February 4, 2015, FDA released draft guidance around its "Expanded Access" program, also known as "compassionate use." The guidance proposes a


FDA issues draft guidance that affects Health IT
  • King & Spalding LLP
  • USA
  • February 2 2015

The U.S. Food and Drug Administration ("FDA") recently issued draft guidance that directly affects health information technology ("Health IT"