When EMA and FDA decisions conflict: differences in patients or in regulation?
@article{Wolfe2013WhenEA, title={When EMA and FDA decisions conflict: differences in patients or in regulation?}, author={S. Wolfe}, journal={BMJ : British Medical Journal}, year={2013}, volume={347} }
In his new regular column Sid Wolfe asks why the two regulatory bodies have arrived at different decisions on the same diet drugs
Topics from this paper
Paper Mentions
13 Citations
Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
- Medicine
- Pharmacoepidemiology and drug safety
- 2015
- 19
A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs
- Medicine
- European Journal of Clinical Pharmacology
- 2018
- 9
Illicit Internet availability of drugs subject to recall and patient safety consequences
- Medicine
- International Journal of Clinical Pharmacy
- 2015
- 13
Evolution of pharmacological obesity treatments: focus on adverse side‐effect profiles
- Medicine
- Diabetes, obesity & metabolism
- 2016
- 83
Medications for the treatment of obesity in adolescents
- Medicine
- Therapeutic advances in endocrinology and metabolism
- 2020
Safety and tolerability profile of new antiepileptic drug treatment in children with epilepsy
- Medicine
- Expert opinion on drug safety
- 2018
- 10
Current Perspectives on Long-term Obesity Pharmacotherapy.
- Medicine
- Canadian journal of diabetes
- 2016
- 15
References
SHOWING 1-10 OF 12 REFERENCES
European regulatory body recommends suspension of rosiglitazone
- Medicine
- BMJ : British Medical Journal
- 2010
- 8
Elevated heart rate: a "new" cardiovascular risk factor?
- Medicine
- Progress in cardiovascular diseases
- 2009
- 81
22529: lorcaserin hydrochloride tablets, 10 mg [FDA briefing document for 10 May 2012 advisory committee meeting
Advisory Committee meeting for phentermine/topiramate (Qnexa) [briefing memo
Application number 022529Orig1s000: approval letter
Clinical briefing document: Endocrinologic and Metabolic Drugs Advisory Committee meeting
FDA approves weight-management drug Qsymia
Medications target long-term weight control