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Draft Guideline of Bioavailability Trials by FDA

Updated: 25 February 2019

There will be guideline update by FDA regarding how to conduct trails by clinical investigators. The update will be done to in line the approval standards with updated science and technology. As per the FDA official, they will also update the review process at each stage of innovative products.

New standard templates will be adopted by CDER in next few months for IND safety and protocol reviews. It will improvise the uniformity of IND reviews through better integration amongst the work of scientific and clinical reviewers. Premarket safety data will also be included in Adverse Event Reporting System. The complete process will become more predictable and structured, as per the FDA official.

As per the draft guideline on Bioavailability Trails, recruitment of only healthy subjects is recommended by the agency for bioavailability trail sponsors. Patients can be enrolled for the study only if there are safety concerns and that too in cases where the disorder is anticipated to remain stable throughout the study duration.