Counterfeit versions of over-the-counter eye drops have been found in Florida and Georgia in stores serving primarily Spanish-speaking customers. These products also may be in Louisiana, Mississippi, North Carolina and potentially other states.
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A majority of the Expedited IND Pilot will take place during the “Pre-IND” phase – the period of nonclinical development before the sponsor submits their official 30-day IND application.
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The application will consist of two sections: 1) Sponsor and Investigative New Drug Information, and 2) Prospective Research Institution Qualifications.
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The FDA Expedited IND Pilot Program is an initiative under HHS Operation TrialBlazer designed to evaluate new approaches for accelerating first-in-human (FIH) clinical trials in the United States while maintaining FDA's rigorous standards for participant safety and scientific oversight.
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These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.
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How you use sunscreens, and what other protective measures you take, make a difference in how well you are able to protect yourself and your family from sunburn, skin cancer, early skin aging and other risks of overexposure to the sun.
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Explore the FDA’s Regulatory Pharmaceutical Fellowship Program, a partnership with academia and industry, offering specialized training in regulatory science, policy, and drug development. Learn how to advance your career in the pharmaceutical field through this unique fellowship opportunity.
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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
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Generic Drugs Offices and Divisions
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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.
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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
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Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.
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