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FDA takes steps to clarify significant human tissue questions

USA - November 4 2015 On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular...

Robert Church, Mike Druckman, Randy Prebula.


Draft guidance on General Considerations for Animal Studies

USA - October 19 2015 On October 14, 2015, the Food and Drug Administration (FDA) released a draft guidance document, General Considerations for Animal Studies for Medical...

Jonathan S. Kahan, Lina R. Kontos, Randy Prebula.


FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

USA - June 14 2018 On June 12 the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidance documents regarding the types of information that drug and...

Jodi Scott, Heidi Gertner, Jennifer Agraz Henderson, Danielle C. Humphrey, Suzanne Levy Friedman, Jane Kalinina, Yetunde Oni, Meredith Manning, Susan S. Lee.


FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

USA - November 28 2018 On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director...

Jennifer Agraz Henderson, Jonathan S. Kahan, Danielle C. Humphrey, Kristin Zielinski Duggan, Janice M. Hogan, Lina R. Kontos, Yarmela Pavlovic, Randy Prebula.


FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance

USA - November 29 2018 On 20 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director...

Jodi Scott, Wil Henderson.