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Results: 11-20 of 80

FDA issues warning letters to web site operators

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 4 2009

On November 19, 2009, FDA completed a coordinated and collaborative international effort intended to curb illegal actions involving medical products sold via the internet

FDA announces Safe Use initiative for drug products

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 4 2009

The Food and Drug Administration (FDA) has announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use

FDA guidance documents

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 4 2009

FDA released a number of final and draft guidance documents in November, including the following

Public hearing on promotion of FDA-regulated medical products using the internet and social media tools

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 4 2009

The FDA recently held a hearing to help the agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies

Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, andor to be relied upon for marketing authorization for pharmaceuticals

Use of Bayesian statistics in medical device clinical trials

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials

Draft guidance on assessment of abuse potential of drugs

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

FDA published a guidance document aimed at sponsors that are developing drug products with the potential for abuse that may need to be scheduled by the Drug Enforcement Agency (DEA) under the Controlled Substances Act

FDA initiative to reduce unnecessary radiation exposure from medical imaging

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

FDA recently announced an initiative seeking to minimize patient exposure to ionizing radiation associated with computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams

Draft guidance on continuing IRB review after clinical investigation approval

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the criteria, process, and frequency of continuing IRB review necessary to ensure that subjects in clinical trials are protected

Guidance on complete submissions for the evaluation of proprietary names

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

To maximize the agency's efforts to process submissions for the evaluation of proprietary names within the deadlines under the Prescription Drug User Fee Act (PDUFA), FDA issued a guidance document to assist manufacturers in making a complete submission, which is required for the PDUFA review clock to begin