Journal français d'ophtalmologie
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We report three cases of optic disc drusen in children. The children were 5 months, 10 years, and 11 years old. Two of them were male. ⋯ Optic disc calcification on CT scan was identified in only one case. In children, optic disc drusen are often buried, leading to pseudopapilledema appearance of the optic disc. Ultrasonography is highly sensitive in detecting optic disc drusen, making more expensive investigations unnecessary.
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Historical Article
[History of the evaluation of medicines aiming for marketing authorization].
The European Directive on Medicines Evaluation and Marketing Authorization were issued in 1975. For more than 30 years, Marketing Authorization criteria have been defined as pharmaceutical and biological quality, therapeutic efficacy, and safety. The application comes from the pharmaceutical company and must include the full data on drug development. French procedures have always included practical assessment of the drug by health practitioners: clinicians, pharmacists, biologists, and specialists in biostatistics.