Australia To Improve Compliance For Device Systems And Procedure Packs
Executive Summary
The Therapeutic Goods Administration is seeking feedback on proposals affecting manufacturers of packages containing therapeutic goods, at least one of which is a medical device or IVD.
You may also be interested in...
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
EMA Says Yes To 12 New Drugs Including Pfizer/AbbVie’s Antibiotic Combo
Emblaveo, for fighting infections caused by multidrug-resistant bacteria, is among the latest batch of medicines that the European Medicines Agency says should be approved for use in the EU.