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Results: 11-20 of 82

FDA seeks comment on co-development of two or more investigational drugs
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA has announced plans to develop guidance and the opening of a public docket for public comment on the co-development of two or more drugs to be used in combination to treat a single disease or condition


FDA and FCC join for public meeting on integration and use of wireless technology with health care devices (July 26-27)
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA and FCC will hold a joint public meeting to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices on July 26 and 27, 2010


FDA guidance on medical device voluntary audit report submission program
  • Reed Smith LLP
  • USA
  • May 25 2010

FDA has issued draft guidance on the implementation of Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA


FDA seeks comments on draft guidance addressing human clinical studies that do not require an IND
  • Reed Smith LLP
  • USA
  • October 28 2010

FDA seeks comments on the agency's draft guidance document entitled ''Investigational New Drug Applications (INDs)Determining Whether Human Research Studies Can Be Conducted Without an IND."


FDA seeks comments on draft guidance concerning drug development tools
  • Reed Smith LLP
  • USA
  • October 28 2010

The Food and Drug Administration (FDA) has issued for public comment a draft guidance entitled "Qualification Process for Drug Development Tools."


FDA proposes changes to the 510(k) program; seeks public comment
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA has made available for comment two reports from internal agency workgroups, one from the Center for Devices and Radiological Health (CDRH) 510(k) Working Group, and another from the Task Force on the Utilization of Science in Regulatory Decision Making


FDA requests notification of intent to participate in medical device user fee reauthorization process
  • Reed Smith LLP
  • USA
  • December 15 2010

FDA has published a notice requesting that patient and advocacy groups notify FDA by January 6, 2011 if they intend participate in a series of public meetings on reauthorization of medical device user fees


FDA guidance on label comprehension studies for over-the-counter (OTC) drugs
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA has issued a guidance document entitled "Label Comprehension Studies for Nonprescription Drug Products" to provide recommendations to industry on conducting label comprehension studies for OTC drug products


FDA withdraws direct final rule requiring the submission of information on pediatric uses of devices
  • Reed Smith LLP
  • USA
  • August 13 2010

As Reed Smith previously reported, FDA issued a direct final rule and a corresponding proposed 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


Guidance on whether radioactive studies require an investigational new drug (IND) application
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA has published a guidance document entitled "The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application," which provides information about the use of radioactive drugs for certain research purposes