EMA: Concept paper on revision of MR NfG [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2010-06-08 18:58 (4862 d 23:14 ago) – Posting: # 5476
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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.

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