Novel Drug Approvals for 2024
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
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MHRA Safety Roundup: May 2025
Summary of the latest safety advice for medicines and medical device users
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Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination
Nipro recalls bicarbonate dialysate concentrate due to contamination. Learn about potential serious injuries, fatality risks and essential steps for healthcare providers and patients for this Class I recall. -
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions -
FDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients. -
Generic Drug Facilities, Sites and Organization Lists
Generic Drug Facilities, Sites and Organization Lists -
Turkana Food Inc. Recall Flora Dried Apricots with Undeclared Sulfites on Product Labeling Because of Possible Health Risk
Turkana Food Inc. Kenilworth, NJ is recalling 352 cases of Floria Dried Apricots because the product contains UNDECLARED SULFITES on the package label. -
ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements
GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics. -
Guidance: GLP-1 medicines for weight loss and diabetes: what you need to know
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
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Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27
Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
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Medtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators and Certain Related Newport™ Service Parts
In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall.
With this recall, Medtronic i -
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration – 05/20/2025
OTC Monograph Drug User Fee Program (OMUFA); Understanding FY 2025 User Fees and Registration