fbpx
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, […]
November 5, 2020

Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes–Exploring the Path Forward for Assessment – 12/11/2020 – 12/11/2020

On This Page Date: December 11, 2020 Time: 9:00 AM – 5:00 PM ET Overview The purpose of the public workshop is to have scientific discussions […]
November 5, 2020

FDA 101: How to Use the Consumer Complaint System and MedWatch

Image FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system […]
November 5, 2020

Jobs in Oncology/Hematology

FDA is recruiting oncologists and hematologists to serve in the dynamic, highly challenging, and innovative atmosphere of oncology drug development and research. Who We Are [embedded […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0