ANDA consolidation policy
FDA reminds generic firms that after Jan. 1, 1991, they will be required to submit multiple strengths and variations of a drug in a single application. The policy guide, issued in May, which outlines the requirements, states that exceptions to the rule must be precleared by the agency.
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Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.