Daniel Yarbrough, Ph.D.

Knobbe Martens

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Latest Posts › Food and Drug Administration (FDA)

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Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the...more

8/22/2018 / Clinical Trials , Food and Drug Administration (FDA) , Intellectual Property Protection , Life Sciences , Medical Research , Microbiome , Scientific Research

FDA Announces Public Meeting on Regulation of Cultured Meat Products

In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat or ”cultured meat” as an alternative to farm-grown meat products. A product...more

6/27/2018 / 3D Printing , Food and Drug Administration (FDA) , Food Manufacturers , Life Sciences , Public Comment , Public Meetings

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

3/7/2018 / Cancer , Clinical Trials , FDA Approval , Federal Pilot Programs , Food and Drug Administration (FDA) , Prescription Drugs

FDA Offers Guidance on Streamlined Development of Treatments for Rare Bacterial Infections

On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals...more

8/21/2017 / Food and Drug Administration (FDA) , Infectious Diseases , Innovation , New Guidance , Personalized Medicine , Pharmaceutical Industry , Prescription Drugs

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

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

4/21/2017 / 23andMe , FDA Approval , Food and Drug Administration (FDA) , Human Genome Project , Medical Devices

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