August 29, 2016 8:27 PM ET

Company Overview of United States Food and Drug Administration

Company Overview

158-15 Liberty Avenue

Jamaica, NY 

United States

Phone:

7183407006

Key Executives for United States Food and Drug Administration

Commissioner
Age: 61
Associate Commissioner for Policy and Planning
Director of New Psychiatry Products Division
Principal Deputy Commissioner and Chief Scientist
Deputy Commissioner of Foods
Compensation as of Fiscal Year 2016.

United States Food and Drug Administration Key Developments

United States Food and Drug Administration Presents at UBS Genomics 2.0 Summit, Aug-11-2016 07:00 PM

United States Food and Drug Administration Presents at UBS Genomics 2.0 Summit, Aug-11-2016 07:00 PM. Venue: St. Regis Deer Valley, Park City, Utah, United States. Speakers: David Litwack, Policy Advisory.

Roche Receives CLIA Waiver for Cobas® Influenza A/B & RSV Test for the Cobas® Liat®

Roche announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B & RSV test for use on the cobas® Liat® System. Roche is to extend the value of highly accurate CLIA-waived molecular testing beyond flu A/B and strep A to include Respiratory Syncytial Virus (RSV), a cause of more than 80% of acute lower respiratory tract infections in infants under one year of age. In the US, an average of 58,000 hospitalizations and 2.1 million outpatient visits in children under five years are attributed to RSV. A significant number is also seen in adults over 65 years with 177,000 hospitalizations and 14,000 deaths per year2. A quick detection and discrimination of flu and RSV enables clinicians to optimize patient management and antiviral treatment. The cobas® Influenza A/B & RSV test is the third assay on the cobas®Liat® System to receive CLIA waiver, following the cobas® Strep A and cobas® Influenza A/B tests, which received CLIA waiver in May and September 2015, respectively. The cobas® Liat® Analyser and all three assays are FDA cleared and CLIA waived.

Loop Industries, Inc. Receives Opinion Letter Confirming FDA Approval of Tertiary PET Recycling Process

Loop Industries, Inc. announced that it has received a positive opinion letter from its FDA counsel confirming that the company's proprietary depolymerization technology enables a tertiary recycling process which the FDA has concluded will result in the production of monomers and oligomers that are sufficiently pure to produce new polymers which can then be readily purified to produce finished polymer such as packaging materials that is suitable for food-contact use. It produces high purity PTA and MEG from post-consumer PET plastic waste streams, meets FDA standards. This approval clears the way for company to accelerate business development activities with food and beverage companies searching for a sustainable packaging solution.

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Recent Private Companies Transactions

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