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Finally, we are adding reference to the proposed subpart Q to the bid rules described at 414.412

Protocol design should mandate negative pregnancy testing at screening and monthly throughout participation, dual contraception methods, and a 90-day post-study contraception period

Benefits of DSIP Here are some of the most commonly documented benefits of DSIP based on the available literature

It will go to the operators who already have the infrastructure pressure-tested: compliant 503A workflow design prescriber onboarding and education sourcing and QA discipline intake clinical review fulfillment throughput policies that hold up under scale, not just demand spikes A lot of organizations are treating this like a product opportunity when its really an operating model test