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Results: 1-10 of 234

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


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 Announces Plans for Three Public Meetings and a Pilot Project Program Under the Drug Supply Chain Security Act
  • Sidley Austin LLP
  • USA
  • July 27 2017

On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled "Enhanced Drug Distribution


U.S. District Court Issues Powerful Decision for Dietary Supplement Industry
  • Sidley Austin LLP
  • USA
  • April 26 2017

On April 18, 2017, Judge Michael Vasquez granted summary judgment to Bayer in a consumer class action over its probiotic


China Food and Drug Administration Simplifies Approval Procedures for Drugs and Medical Devices
  • Sidley Austin LLP
  • China
  • April 11 2017

The China Food and Drug Administration (CFDA) published two announcements on April 5 and 6, 2017, delegating some of its approval authority for drugs


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


Senate HELP Committee Holds Hearing on Food and Drug Administration User Fee Agreements
  • Sidley Austin LLP
  • USA
  • March 29 2017

On March 21, the Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on the Food and Drug Administration (FDA) user


House Energy and Commerce Subcommittee Holds Hearing on Food and Drug Administration Prescription Drug User Fees
  • Sidley Austin LLP
  • USA
  • March 29 2017

On March 22, the U.S. House of Representatives Energy and Commerce Health Subcommittee held a hearing on the reauthorization of the Prescription Drug


House Health Subcommittee Holds Hearing on User Fee Program Reauthorizations and Generic Drug Competition Bill
  • Sidley Austin LLP
  • USA
  • March 15 2017

The U.S. House of Representatives Energy and Commerce Health Subcommittee held a hearing March 2 to consider reauthorization of the Food and Drug


Sen. Sanders Introduces Drug Importation Bill on Feb. 28
  • Sidley Austin LLP
  • OECD, USA
  • March 15 2017

On Feb. 28, Sen. Bernie Sanders, I-Vt., introduced S. 469, The Affordable and Safe Prescription Drug Importation Act, which would amend the Federal