Contraindication labelling changes in the United States and Germany

Author:

Garbe Edeltraut,Andersohn Frank

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference30 articles.

1. Murphy S, Roberts R (2006) “Black box” 101: how the food and drug administration evaluates, communicates, and manages drug benefit/risk. J Allergy Clin Immunol 117:34–39

2. US Food and Drug Administration (2006) Guidance for industry. Development and use of risk minimization action plans. http://www.fda.gov/cder/guidance/6358fnl.pdf

3. European Commission (2006) Notice to applicants: a guideline on summary of product characteristics revision 1

4. Reggi V, Balocco-Mattavelli R, Bonati M, Breton I, Figueras A, Jambert E, Kopp C, Montane E, Rago L, Rocchi F (2003) Prescribing information in 26 countries: a comparative study. Eur J Clin Pharmacol 59:263–270

5. US Food and Drug Administration (2006) MedWatch safety information. Safety-related drug labeling changes. http://www.fda.gov/medwatch/safety.htm

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