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May 27, 2020

Musthavemom.com – 607749 – 05/26/2020

Product: Drugs Date:               May 26, 2020 CC:                  [email protected] – Amazon Associates Program RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) […]
May 27, 2020

Careful Cents, LLC – 607756 – 05/26/2020

Product: Drugs Recipient: Recipient Name Carrie Lee Smith Nicholson Careful Cents, LLC 6671 Bugle DriveColorado Springs, CO 80918United States [email protected] Date:               May 26, 2020 CC:                  […]
May 27, 2020

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 […]
May 27, 2020

Submission of Abbreviated Reports and Synopses in Support of Marketing Applications.

Docket Number: FDA-1998-D-0141 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document provides guidance to applicants […]
May 27, 2020

Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.

Docket Number: FDA-1997-D-0027 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document is intended to provide […]
May 27, 2020

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is being issued to […]
May 27, 2020

FDA Approves Only Drug in U.S. to Treat Severe Malaria

For Immediate Release: May 26, 2020 Today, the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. […]
May 26, 2020

Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil

Summary Company Announcement Date: July 21, 2017 FDA Publish Date: February 08, 2018 Product Type: Dietary SupplementsDrugsNutritional SupplementGeneric Drugs Reason for Announcement: Recall Reason Description Unapproved […]
May 26, 2020

Vitility Issues Voluntary Nationwide Recall of Man of Steel Due to Presence of Undeclared Sildenafil

Summary Company Announcement Date: August 03, 2017 FDA Publish Date: February 08, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of […]
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