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October 12, 2023
Quality Considerations for Topical Ophthalmic Drug Products
October 4, 2023
Stimulant Use Disorders: Developing Drugs for Treatment
September 28, 2023
This draft guidance introduces submitters of De Novo requests to CDRH and CBER the associated content to support De Novo electronic submissions to FDA.
September 28, 2023
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
September 25, 2023
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.
September 22, 2023
Blue Cross Blue Shield Louisiana announced earlier this year a desire to sell the non-profit health insurance company to Elevance Health, a for-profit provider. Policyholders are letting the Louisiana Department of Insurance know they aren't happy about it.
September 22, 2023
Blue Cross Blue Shield Louisiana announced earlier this year a desire to sell the non-profit health insurance company to Elevance Health, a for-profit provider. Policyholders are letting the Louisiana Department of Insurance know they aren't happy about it.
September 22, 2023
Blue Cross Blue Shield Louisiana announced earlier this year a desire to sell the non-profit health insurance company to Elevance Health, a for-profit provider. Policyholders are letting the Louisiana Department of Insurance know they aren't happy about it.
September 21, 2023
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products
September 18, 2023
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence