FDA Adds 35 Bioequivalence Guidances, Updates 12 More

Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more.

The documents — which range in length from one to eight pages — spell out what data are expected to substantiate bioequivalence for that particular product. They address a multitude of metrics — including the number and types of studies required, the target participants and the threshold for success.

All of the draft guidance documents were either issued or updated in January, according to the FDA. This was the first update to the list since last September.