Log in
RegisterEMA: Concept paper on revision of MR NfG [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2010-06-08 18:58 (4862 d 23:14 ago) – Posting: # 5476
Views: 3,950
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.
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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA: Concept paper on revision of MR NfGHelmut 2010-06-08 16:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz