Challenges in TB regimen development: preserving evidentiary standards for regulatory decisions and policymaking

Expert Rev Anti Infect Ther. 2020 Aug;18(8):701-704. doi: 10.1080/14787210.2020.1756776. Epub 2020 Apr 28.

Lorenzo Guglielmetti^{1

2

3}, Marcus Low^{4

5

6}, Lindsay McKenna^{5

7}

¹ Médecins Sans Frontières , Paris, France.
² Sorbonne Université, INSERM, U1135, Centre d'Immunologie Et Des Maladies Infectieuses , Paris, France.
³ APHP, Groupe Hospitalier Universitaire Sorbonne Université, Hôpital Pitié-Salpêtrière, Centre National De Référence Des Mycobactéries Et De La Résistance Des Mycobactéries Aux Antituberculeux , Paris, France.
⁴ Department of Computer Science, PhD Candidate, University of Cape Town , Cape Town, South Africa.
⁵ Global Tuberculosis Community Advisory Board , New York, New York, USA.
⁶ Spotlight , Cape Town, South Africa.
⁷ Treatment Action Group , New York, USA.

No abstract available

Keywords: EMA; FDA; MDR-TB; Tuberculosis; WHO; XDR-TB; clinical trial; drug resistance; new drug.

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