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Results: 11-20 of 82

FDA issues final regulations requiring the submission of information on pediatric populations for devices
  • Reed Smith LLP
  • USA
  • April 16 2010

The Food and Drug Administration (FDA) has issued a direct final rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients


FDA guidance on enforcement of regulations restricting sale and distribution of cigarettes & smokeless tobacco
  • Reed Smith LLP
  • USA
  • May 13 2010

FDA has issued a guidance document entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco."


FDA experimental study of patient information prototypes
  • Reed Smith LLP
  • USA
  • May 13 2010

FDA seeks public comment on a study being conducted by the agency that is designed to test different ways of presenting information about prescription drugs to patients


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


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


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


FDA’s emerging internet policy: themes and recommendations from public hearing on promotion of FDA-regulated medical products using the internet and social media tools
  • Reed Smith LLP
  • USA
  • November 27 2009

Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications


FDA and NIH announce collaboration to speed patient access to new therapies
  • Reed Smith LLP
  • USA
  • February 26 2010

FDA and the National Institutes of Health (NIH) have announced a new initiative aimed at improving efficiencies in translational science and regulatory science to close the gap in time between discovery of new technology and availability of therapies to patients