Generic Drug Development
Information for generic drug development assistance, generic drug approvals, and generic drug regulatory resources.
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Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment
Baxter is removing mobile lift components due to risk of false attachment, which may result in patient injury due to falls. -
Summer ready: MHRA issues updated guidance on medicines and medical devices during holiday season
As the UK enters the heart of summer – with temperatures rising and families holidaying – the Medicines and Healthcare products Regulatory Agency (MHRA) is reinforcing essential safety advice for anyone using medicines or medical devices.
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Form: Decentralised Manufacture: The designation step application form
Application Form to be completed by an Applicant and sent to the MHRA requesting consideration of an award of a Decentralised Manufacture (DM) Designation.
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Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
New regulations effective today will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated.
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Early Alert: Infusion Pump Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Commissioner’s National Priority Voucher (CNPV) Pilot Program
FDA Commissioner’s National Priority Voucher Program. The Commissioner’s National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months. -
Commissioner’s National Priority Voucher (CNPV) Pilot Program Submission
This new pilot program is designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans. -
FDA Adverse Event Reporting System (FAERS) Electronic Submissions
This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing -
Missouri Analytical Laboratories Inc – 615319 – 10/09/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated -
IndulgeRx Brands, Inc – 703668 – 06/16/2025
New Drug/Misbranded -
Glenmark Pharmaceuticals Limited – 708270 – 07/11/2025
CGMP/Finished Pharmaceuticals/Adulterated