FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19
The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022
The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Collecting and Providing 702(b) Portions of FDA Official Samples
- Questions and Answers (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Alma LeVant Hayden's Contributions to Regulatory Science
Virtual exhibit about former Director of the Spectrophotometry Branch, Alma Hayden (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 20, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer
. FDA approvs new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine
Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zer (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee ® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee ® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance - 02/10/2022
Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC) - 11/18/2021
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) welcome you to this FDA Virtual Public Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

GeroNova Research Inc. - 612777 - 11/18/2021
Internet Marketing of Unapproved and Misbranded Drugs (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop - 610751 - 09/20/2021
Compounding Pharmacy/Adulterated Drug Products (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Professional Disposables International, Inc. - 617201 - 01/07/2022
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cosmo Bio Co., Ltd. - 611552 - 01/06/2022
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Genesis Partnership Company SA - 618953 - 12/29/2021
Drug Product/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 18, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news