We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 11-20 of 82

FDA requests notices of intent to participate in periodic PDUFA reauthorization meetings
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA has issued a notice to stakeholders requesting that those parties intending to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA) notify the agency


FDA guidance on bioequivalence study design for specific products
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA has issued a guidance document entitled "Bioequivalence Recommendations for Specific Products," which announces that FDA will make available recommendations on study design for particular products on the agency's website


FDA to post new on-line information regarding safety monitoring issues for recently-approved drugs and biologics
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA announced a new initiative, required under the Food and Drug Administration Amendments Act of 2007, to post summaries of FDA safety analyses and the agency's plan to address them on the FDA website


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 meeting on patient medication information for prescription drugs
  • Reed Smith LLP
  • USA
  • August 30 2010

FDA announced a two-day public hearing to be held on September 27 -28, 2010 to seek public input on a new framework for the development and distribution of patient medication information (PMI) to be provided to patients with prescription drug products


FDA meeting on medical devices and nanotechnology: manufacturing, characterization, and biocompatibility considerations
  • Reed Smith LLP
  • USA
  • August 30 2010

FDA will hold a public meeting on September 23, 2010 to seek input on the manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics


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


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