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- Title
On criteria to evaluate the therapeutic innovation of drugs.
- Authors
Motola, Domenico; Montanaro, Nicola
- Abstract
As authors of two papers proposing the "old" algorithm to assess the therapeutic innovation of the medicines approved by the EM(E)A between 1995 and 2003,1,2 we have read with great interest and curiosity the paper by Filomena Fortinguerra et al. entitled "Using GRADE methodology to assess innovation of new medicinal products in Italy."3 These authors rightly write that the Italian Medicines Agency (AIFA) was the first regulatory body to introduce a method for acknowledging and ranking the therapeutic innovation when it adopted our algorithm in 2007.4 As former chairman (NM) and member (DM), on behalf of AIFA, of the 2007-AIFA/Industry working group commissioned to support such adoption, we had to arrange a few significant changes on the initial published algorithm. Of course, we fully admit the right of AIFA to adopt new and perhaps more advanced tools for assessing therapeutic innovation, but at the same time, we claim the value of our algorithm methodology, which has received significant acknowledge in the literature.
- Subjects
DRUGS; SUDDEN infant death syndrome; DRUG analysis
- Publication
British Journal of Clinical Pharmacology, 2021, Vol 87, Issue 5, p2403
- ISSN
0306-5251
- Publication type
Article
- DOI
10.1111/bcp.14650