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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 […]
November 6, 2020

CDER’s Efforts to Help Improve the Quality of Drug Compounding Include an Ongoing Focus on Insanitary Conditions

Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of […]
November 6, 2020

Insanitary Conditions at Compounding Facilities Guidance for Industry

Docket Number: FDA-2016-D-2268 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C […]
November 5, 2020

Custom Compounding Center – 481888 – 10/28/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mark W. Shinabery Recipient Title Owner and Pharmacist-In-Charge Custom Compounding Center 11700 Kanis RdSuite 1Little Rock, […]
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