Helmut ★★★ Vienna, Austria, 2018-06-26 16:40 (2122 d 21:43 ago) Posting: # 18968 Views: 6,100 |
|
Dear all, on 31 May the EMA’s CHMP adopted new product-specific guidance (effective with 1 December 2018):
I suggested to delete “Comparable median and range for tlag” from the second one: Comment:
Proposed change: Was obviously accepted (even tmax removed…) but comments not published. Am I a persona non grata? — 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 |
mmw ☆ India, 2018-06-29 09:20 (2120 d 05:03 ago) @ Helmut Posting: # 18993 Views: 5,077 |
|
Dear All, EMA published new product specific draft guidances for public consultation.
Regards, MMW Edit: Links added; end of consultation 30 September 2018. [Helmut] |
Helmut ★★★ Vienna, Austria, 2018-07-05 17:11 (2113 d 21:12 ago) @ mmw Posting: # 19023 Views: 4,909 |
|
Dear All, today the EMA published another one for public consultation. — 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 |
Helmut ★★★ Vienna, Austria, 2018-08-03 18:52 (2084 d 19:31 ago) @ Helmut Posting: # 19133 Views: 4,638 |
|
Dear all, today the EMA published another set of product-specific guidances (adopted by the CHMP 26 July, effective with 2 February 2019): — 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 |