FDA to reduce number of trials required for drug approvals, STAT reports

The FDA plans to generally require only one clinical study, rather than the traditional two, for medical product approvals, according to Commissioner Marty Makary, STAT’s Lizzy Lawrence reports. While two trials will still be required in certain cases, the default approach will shift to a single pivotal study, reflecting current industry practices, according to the report. Publicly traded companies in the space include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).