Generic Drug Facilities, Sites and Organization Lists
Generic Drug Facilities, Sites and Organization Lists
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FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds - 08/25/2026
On August 25, 2026, the U.S. Food and Drug Administration (FDA) is hosting a hybrid public meeting on Patient-Focused Drug Development for Nonhealing Chronic Wounds.
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.
FDA Drug Competition Action Plan
FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
Determining Whether to Submit an ANDA or a 505(b)(2) Application
Determining Whether to Submit an ANDA or a 505(b)(2) Application
American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass an
Determining Whether to Submit an ANDA or a 505(b)(2) Application
Determining Whether to Submit an ANDA or a 505(b)(2) Application
Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter
July 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of particulate matter identified as steel. To date, no adverse events or injuries associated with this pa
What's New Related to Drugs
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
Newly Added Guidance Documents
Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
CDER Leadership Bios
CDER Leadership Bios
Addressing the Public Health Effects of Opioid Medications - 09/09/2026
On September 9, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA (Foundation), will convene a public meeting to hear public comments on perspectives regarding the use of opioid medications for the management of pain and addiction.
Generic Drug User Fee Amendments
This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
The Center for Research on Complex Generics
FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).
FDA/Center for Research on Complex Generics (CRCG) Workshop on Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods - 10/14/2026
Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, October 14-15, 2026.
Withdrawn | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Container Closure Systems for Human Drugs and Biological Products
Container Closure Systems for Human Drugs and Biological Products
Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA) - 09/16/2026
The Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.
Completed BsUFA III Deliverables
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.