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May 18, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 18, 2020

For Immediate Release: May 18, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 18, 2020

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung […]
May 18, 2020

Ridge Properties DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of all Lots of Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid Products Due to Manufacturing Concerns at the Facility

Summary Company Announcement Date: October 31, 2017 FDA Publish Date: December 29, 2017 Product Type: DrugsOver-the-Counter Drugs Reason for Announcement: Recall Reason Description Manufacturing Concerns Company […]
May 18, 2020

Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues

Summary Company Announcement Date: November 29, 2017 FDA Publish Date: December 29, 2017 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Lack of […]
May 18, 2020

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) […]
May 18, 2020

COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products

Image By: Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs The U.S. Food and Drug Administration continues to use all tools and flexibilities available to […]
May 18, 2020

The Golden Road Kratom – 607627 – 05/15/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Date:               May 15, 2020 RE:                  Unapproved and Misbranded Products Related […]
May 18, 2020

Noetic Nutraceuticals – 607572 – 05/15/2020

Product: Drugs Recipient: Noetic Nutraceuticals 8835 Columbia 100 PKWY, Ste DColumbia, MD 21045United States [email protected] Date:               May 15, 2020 RE:                  Unapproved and Misbranded Products […]
May 17, 2020

Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer Due to Microbial Contamination

Summary Company Announcement Date: November 24, 2017 FDA Publish Date: December 29, 2017 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Microbial Contamination (Scopulariopsis […]
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