A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more
The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more
On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more
FDA Hosts Genome Scientists For Next-Generation Sequencing Conference - Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public...more
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more
In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more
In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more