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Securing FDA approval requires the submission of pre-clinical, clinical and/or pharmacokinetic data, information about product manufacturing processes and inspection of facilities and supporting information to the FDA for each therapeutic indication to establish a product candidates safety and efficacy for each indication

They vary in duration depending on individual tolerance levels and the amount consumed

That is the number of live, viable bacteria per dose

Intravenous (IV) Therapy 5.4.2.3.6