Follistim-AQ “not approvable”
Executive Summary
Organon will meet with FDA in the next few weeks to discuss "not approvable" letter for Follistim-AQ Cartridge, the ready-to-use version of the fertility product follitropin. FDA requested more data...
You may also be interested in...
Organon Follistim Sales Aid Cited For Misleading Cost-Effectiveness Claims
An Organon sales brochure for the infertility agent Follistim makes misleading cost-effectiveness claims, FDA's Division of Drug Manufacturing, Advertising & Communications said in a Dec. 12 letter
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.