Dec 05 2013

New FDA Guidances for November 2013

There were plenty of interesting releases from FDA in November.  Near and dear to my own research heart was the finalization of the guidance for the Preclinical Assessment of Investigational Cellular and Gene Therapy Products.  Also, if you’re interested in a scathing read, check out FDA’s warning letter to genetic testing company 23andMe.  The company has since stopped the sales of its genetics testing kit, and it will be interesting to see if 23andMe will pursue clearances and approvals similar to those recently granted to competitor Illumina.

Special Interest Guidances/Information

Date Posted

Pulmonary Tuberculosis: Developing Drugs for Treatment

05 Nov 2013

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

07 Nov 2013

Design Considerations for Pivotal Clinical Investigations for Medical Devices

07 Nov 2013

Medical Device Development Tools

14 Nov 2013

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

18 Nov 2013

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only

25 Nov 2013

Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation

Nov 2013

Preclinical Assessment of Investigational Cellular and Gene Therapy Products

Nov 2013