Sam Siegfried

Aug 12, 2024 | lexology.com | James Ravitz |Jiayan Chen |Paul S. Gadiock |Jennifer S. Geetter |Jeff Weinstein |Sam Siegfried | +2 more

On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance.

Sep 6, 2023 | jdsupra.com | Jennifer S. Geetter |Anisa Mohanty |Sam Siegfried

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.

Sep 6, 2023 | lexology.com | Jennifer S. Geetter |Anisa Mohanty |Sam Siegfried

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.

Aug 16, 2023 | jdsupra.com | Jennifer S. Geetter |Sam Siegfried |Alya Sulaiman

Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law enforcement, agriculture and wellness testing. However, these advances have simultaneously escalated cybersecurity risks associated with the collection, processing, and maintenance of genomic data.

Aug 15, 2023 | lexology.com | Jennifer S. Geetter |Sam Siegfried |Alya Sulaiman

To view this article you need a PDF viewer such as Adobe Reader. If you can't read this PDF, you can view its text here. Go back to the PDF. USAAugust 15 2023INTRODUCTIONRemarkable progress in DNA and RNA sequencing have democratized thegeneration and analysis of genomic data across diverse industry sectors,including biopharmaceutical research, healthcare, consumer ancestry, lawenforcement, agriculture and wellness testing.