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November 10, 2020

Natural Sprout Co. LLC – 610151 – 10/29/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Stephen F. Aton Recipient Title Member Natural Sprout Co. LLC 1571 E. Cherokee StreetSpringfield, MO 65804United States […]
November 10, 2020

FDA Insight: Hand Hygiene During COVID-19

Dr. Shah welcomes Elizabeth Jungman, director of CDER’s Office of Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic. FDA Insight: Episode 18 – […]
November 10, 2020

Coronavirus (COVID-19) Update: November 9, 2020

For Immediate Release: November 09, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
November 9, 2020

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

For Immediate Release: November 09, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab […]
November 9, 2020

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

Summary Company Announcement Date: November 09, 2020 FDA Publish Date: November 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May be contaminated with […]
November 9, 2020

Office of Biotechnology Products

WHO WE ARE:The Office of Biotechnology Products (OBP) protects and advances the public health through review, regulation, and research of biological products and biosimilar biological products. […]
November 9, 2020

Office of Quality Surveillance

WHO WE ARE:The Office of Quality Surveillance (OQS) continuously monitors and provides the state of quality for all regulated sites and products. WHAT WE DO: Assures […]
November 9, 2020

Office of Testing & Research

WHO WE ARE:The Office of Testing and Research operates as an integrated testing and research FDA laboratory to develop scientific methods and tools to assess pharmaceutical […]
November 9, 2020

Office of New Drug Products

WHO WE ARE: The Office of New Drug Products (ONDP) conducts risk and team-based, cross-office collaborative quality assessments of Investigational New Drug (IND) submissions, original and some […]
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