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Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry
Electronic Submissions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 1, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: March 29, 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 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities - 05/08/2024
Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment Role and Opportunities (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Conceptos b ásicos sobre biosimilares para pacientes
Los biosimilares son medicamentos seguros y eficaces para el tratamiento de muchas enfermedades como la artritis y el c áncer. Obtenga información sobre los biosimilares y cómo benefician a los pacientes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Biosimilars Basics for Patients
Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. Learn about biosimilars and how they benefit patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: LITFULO
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 28, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) Due to Presence of White Particles
East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white par (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 28, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Special Features
links to articles, podcasts, etc (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval - 05/09/2024
Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Statistical Considerations for Premarketing Risk Assessment - 05/16/2024
Statistical Considerations for Premarketing Risk Assessment (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Proposed Rule)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: March 26, 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 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
FDA warns consumers not to use certain over-the-counter pain relief products containing lidocaine that are marketed for topical use in cosmetic procedures like microdermabrasion, laser hair removal, tattooing and piercing, and issued warning letters to six companies for violating of federal law. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Indelicare DBA INKEEZE - 671656 - 03/25/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news