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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 […]
November 9, 2020

Office of Lifecycle Drug Products

WHO WE ARE:The Office of Lifecycle Drug Products (OLDP) assures drug product quality during the lifecycle of both brand name and generic drug products.   WHAT WE DO: […]
November 9, 2020

Office of Policy for Pharmaceutical Quality

WHO WE ARE:The Office of Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and clearly communicating science and risk-based policies and standards related to drug […]
November 9, 2020

Office of Program & Regulatory Operations

WHO WE ARE:The Office of Program and Regulatory Operations (OPRO) is a customer-oriented, regulatory-focused, and process-centered organization that leads OPQ’s operational framework to foster collaboration, efficiency, and quality. WHAT […]
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