Bioequivalence and Bioavailability Forum

Dear all,

the "Concept paper on the need for revision of the note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation)" (EMA/CHMP/EWP/1303/2010) was just published on EMA's website.
Deadlines for comments is 31 August 2010; It is anticipated that a draft revision will be released 15 months after adoption of the Concept Paper. The public consultation on the draft revision will last for 6 months. Following the receipt of comments the revision will be finalised within approximately 6 months.