FDA tweaks and fi­nal­izes bioavail­abil­i­ty study guid­ance, but most­ly ig­nores Pfiz­er and Mer­ck sug­ges­tions

Ever since Rob Califf won Sen­ate con­fir­ma­tion as FDA com­mis­sion­er, the trick­le of new guid­ance doc­u­ments for the bio­phar­ma in­dus­try has be­come a steady stream.

On Thurs­day, the agency re­leased two more guid­ance doc­u­ments — one new draft on the FDA’s cur­rent rec­om­men­da­tions on clin­i­cal tri­als for drugs to treat celi­ac dis­ease as an ad­junct to a gluten-free di­et in adults, and an­oth­er 30-page fi­nal guid­ance on the bioavail­abil­i­ty stud­ies sub­mit­ted in­side of new drug ap­pli­ca­tions and IND re­quests for clin­i­cal tri­als.

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