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Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

The FDA Law Blog

Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. The Draft Guidance emphasizes that study team should not answer the questions based on observation or even on existing medical records.

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Levonorgestrel Intrauterine Device for Emergency Contraception

Birth Control Pharmacist

Participants were instructed to follow-up one month after IUD insertion for a urine pregnancy test, but even if they did not follow-up, their medical records for the following six months were reviewed to verify if a pregnancy was ever detected. 2011; 117:1105-13. Why the Levonorgestrel IUD? Am J Public Health. 2018; 108:550-6.