FDA and EMA Launch Parallel Scientific Advice Pilot Program for Complex Generics
Pilot program works to increase harmonization and bring generic drugs to patients (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 7, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Tianeptine
FDA alerts and notices regarding tianeptine (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: February 6, 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 - February 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Les Importations Herbasant é Inc. - 668412 - 01/31/2024
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 - February 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Ehy Holdings, LLC - 675591 - 02/02/2024
Failure to Register and List (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Nantong Furuida Packaging Products Co., Ltd. - 667984 - 11/17/2023
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 - February 6, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil
“Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil (structurally similar to Tadalafil). Tadalafil and Norta dala (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil
“Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared Nortadalafil (structurally similar to Tadalafil). Nortadalafil is an active drug ingredient known for treatment of male ere (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD & C Act
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING ® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene
Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company ( “Insight”), is voluntarily recalling two lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lot (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: February 2, 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 - February 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Master File (DMF) Submissions on New FDA Form 3938 - 01/13/2021
Drug Master File (DMF) Submissions on New FDA Form 3938 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA warns consumers of contaminated copycat eye drops
FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye infection. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 31, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Arize contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Arize, a product promoted and sold for sexual enhancement on various websites, including www.getarize.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: January 30, 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 - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news