月曜日, 3月 02, 0021

20090227 EMEA guidance, concept paper, reflection paper

27/02/09 Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder (pmdd)
http://www.emea.europa.eu/pdfs/human/ewp/1187709en.pdf

27/02/09 Guideline on clinical development of fixed combination medicinal products
- Overview of comments received on above draft guideline
http://www.emea.europa.eu/pdfs/human/ewp/024095enfin.pdf
http://www.emea.europa.eu/pdfs/human/ewp/53306608en.pdf

27/02/09 Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive pulmonary disease (copd)
http://www.emea.europa.eu/pdfs/human/ewp/819709en.pdf

27/02/09 Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections
http://www.emea.europa.eu/pdfs/human/ewp/43563508en.pdf

27/02/09 Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease (gerd)
http://www.emea.europa.eu/pdfs/human/ewp/1583909en.pdf

27/02/09 Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population
http://www.emea.europa.eu/pdfs/human/ewp/69270208en.pdf

27/02/09 Guideline on Xenogeneic Cell-based medicinal products
http://www.emea.europa.eu/pdfs/human/cpwp/8350809en.pdf

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