US FDA to revise contact lens guidance in effort to reduce eye infections
This article was originally published in SRA
The US Food and Drug Administration is planning to update some of its contact lens and lens solution testing and labeling standards in an effort among other things to prevent potential eye infections related to the products. The FDA will seek input on its plans from its ophthalmic device advisory panel on 13 May1,2.
You may also be interested in...
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.