2011, Drug Development and Medical Records

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2011

Drug Development

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

DECEMBER 14, 2023

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 As of October 2023, 62.93

Medical Records

Medical Records Vaccines Hospitals Drug Development

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

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance.

Medical Records

Medical Records Drug Development

Pharmacist Digest

Understanding the evidence used in drug product withdrawals

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

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