Mentor silicone submission
This article was originally published in The Gray Sheet
Executive Summary
Mentor has filed a PMA for its Contour Profile silicone gel breast implants, firm announces April 3. The Contour implants are filled with the same Memory Gel for which Mentor received an "approvable" letter for round implants from FDA last summer. Competitor Allergan/Inamed's silicone gel breast implants also sit on a September "approvable" letter. Though neither company will speculate, analysts project FDA approval of both firms' products as early as June 2006 (1"The Gray Sheet" April 3, 2006, p. 6). Furthering its shift to aesthetics, Mentor signed an agreement with Niadyne Inc. on March 20 to distribute Niadyne's NIA 24 skin therapy products...
You may also be interested in...
Allergan Details Revenue Expectations From Newly Acquired Inamed
Allergan expects its recently completed acquisition of Inamed to add $355 mil. to $395 mil. in sales revenue this year
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
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.