Draft Guidance on Biological Products Issued By FDA
Modern Healthcare (2/12, Lee, Subscription Publication) reported, “The Food and Drug Administration issued draft guidance addressing the amounts and types of safety data that companies developing drug and biological products should collect in late-stage, pre-market and post-market clinical investigations.”
The FDA “said in the draft guidance that ‘more selective safety data collection’ could improve the safety database, ease the burden on clinical investigators and participating patients, and lower costs.”
The agency also said that “in some late-stage, pre-market and post-market clinical trials, a drug safety profile may already be established and comprehensive data should not be required.”
