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We are proposing to amend proposed redesignated 412.87(f)(2) to reflect this proposed change by revising the date by which new medical services or technologies must receive FDA marketing authorization from July 1 to May 1 and making other conforming changes to the regulatory text

Among the salient indications, inhaled NO is used for acute pulmonary vasoreactivity testing and severe hypoxia in pulmonary arterial hypertension (PAH), nitrates are used extensively in ischemic heart disease and heart failure, sGC stimulators and activators are used for PAH, and PDE5 inhibitors are used for erectile dysfunction, PAH and benign prostatic hyperplasia

Ghule AE, Kulkarni CP, Bodhankar SL, Pandit VA

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