CLIA transfer
This article was originally published in The Gray Sheet
Executive Summary
FDA intends to provide guidance on how requests for categorizations under the Clinical Laboratory Improvement Amendments of 1988 will be "administratively processed," the agency says in an Aug. 23 letter to in vitro diagnostic makers. The guidance will be made available prior to Jan. 31, 2000, the time at which the agency will begin handling the categorization duties currently conducted by the Centers for Disease Control and Prevention (1"The Gray Sheet" April 19, p. 3). A website also will be created to assist manufacturers with the transfer, FDA says
You may also be interested in...
CLIA Complexity Categorization Transfer From CDC To FDA Under Way
FDA expects to assume all duties related to the categorization of in vitro diagnostics conducted under the Clinical Laboratory Improvement Amendments from the Centers for Disease Control and Prevention by Jan. 31, 2000.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.