Quality Considerations for Topical Ophthalmic Drug Products
Quality Considerations for Topical Ophthalmic Drug Products
Source: fda.gov
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Stimulant Use Disorders: Developing Drugs for Treatment
Stimulant Use Disorders: Developing Drugs for Treatment
Source: fda.gov
Electronic Submission Template for Medical Device De Novo Requests
This draft guidance introduces submitters of De Novo requests to CDRH and CBER the associated content to support De Novo electronic submissions to FDA.
Source: fda.gov
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment
The purpose of this guidance is to assist sponsors in the clinical development of drugs, biological products, therapeutic devices, and cell processing devices for the prevention or treatment
Source: fda.gov
CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
This guidance provides recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on medicated feed of food-producing animals that are currently approved with one or more indications that lack a defined duration of use.
Source: fda.gov