The Trump administration was previously skittish about publicly touting its changes to vaccine policy, which was seen as politically unpopular.
Investigator-initiated trials have fueled China's biomedical research and red-hot biotech industry. But they have also come under new scrutiny.
ITM Isotope Technologies Munich said the agency cited manufacturing issues in its letter rejecting the radiopharmaceutical treatment.
Radiopharmaceuticals have grabbed the drug industry’s attention, but in clinical trials, developers are seeing the problems with isotopes.
The problem emerged shortly after the FDA warned the company over manufacturing issues at the Irish facility where the drugs are made.
The drug, designed to treat a condition known as PH-HFpEF, is the company's lone candidate and is being tested in a second Phase 3 study.
New policy would stop short of "closing the GRAS loophole" but for first time will document previously unknown chemicals used in American food.
The company had been testing whether the drug, SION-719, could boost benefits when used with Vertex's blockbuster Trifkafta.
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