Remove 2011 Remove Biosimilars Remove Medical Records
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2021 market access prospects for Germany

pharmaphorum

IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers. Any changes to AMNOG will likely be a worry to industry as there has already been a toughening in AMNOG assessments since 2011.”. Figure 1: AMNOG procedures and findings, 2011-2019. Tougher pricing?

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

FDA Law Blog: Biosimilars

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.