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Rigorous Detection of Nitrosamine Contaminants in Metformin Products: Balancing Product Safety and Product Accessibility
Nitrosamines are a class of chemicals that commonly occur as impurities in water, beverages, and foods (particularly in cured and grilled meats). Although nitrosamines are generally regarded to be carcinogenic, small amounts of exposure are not considered to be harmful. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Spirochaete Research Labs, LLC aka Scitus Laboratory Products - 674278 - 03/08/2024
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: ORSERDU
ORSERDU is a drug for the treatment of postmenopausal females and adult males with a specific form of advanced breast cancer that progressed after previous treatment with endocrine therapy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA issues guidance regarding drug development for early Alzheimer ’s disease
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Early Alzheimer ’s Disease: Developing Drugs for Treatment
Clincal / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2023 First Generic Drug Approvals
Each year, FDA ’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for pati (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: March 8, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight
The FDA approved a new use for a drug to reduce the risk of cardiovascular disease, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

POSTPONED: January 22, 2016 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee - 01/21/2016
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

June 9, 2016: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement - 06/08/2016
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

July 19, 2016: Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement - 07/18/2016
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

November 4, 2016: Meeting of the Antimicrobial Drugs Advisory Committee - 11/03/2016
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

April 13, 2017: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement - 04/12/2017
This page contains the meeting materials for the Antimicrobial Drugs Advisory Committee meetings for 2017, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

August 2, 2017: Meeting of the Arthritis Advisory Committee Meeting Announcement - 08/01/2017
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news