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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 […]
November 9, 2020

Office of Pharmaceutical Manufacturing Assessment

WHO WE ARE:The Office of Pharmaceutical Manufacturing Assessment (OPMA) assures that quality pharmaceuticals are consistently manufactured over the product lifecycle. WHAT WE DO: Leads the assessment of manufacturing […]
November 9, 2020

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry

Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Over the past few decades, FDA has promoted enrollment practices that would […]
November 9, 2020

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry

Docket Number: FDA-2017-D-5913 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides stakeholders information regarding […]
November 7, 2020

Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products

Summary Company Announcement Date: October 31, 2019 FDA Publish Date: November 01, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potentially contain microbial contamination […]
November 7, 2020

Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product

Summary Company Announcement Date: October 23, 2019 FDA Publish Date: October 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of N-Nitrosodimethylamine (NDMA) […]
November 6, 2020

FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance

For Immediate Release: November 06, 2020 Statement From: Statement Author Leadership Role Director – Center for Drug Evaluation and Research Patrizia Cavazzoni M.D. Protecting patients from […]
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