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Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment

Generics

On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires.

Over-the-Counter Monograph Order Requests: Format and Content; Draft Guidance for Industry; Availability

This guidance provides recommendations for the design and conduct of studies to evaluate the in 17 vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery 18 system (collectively referred to as TDS2).

This guidance clarifies current approaches and recommendations for Human User Safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.

On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency...

Marketing Submission Recommendations for Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions

This guidance provides recommendations to help sponsors complete the effectiveness, target animal safety, and labeling technical sections of a new animal drug application (NADA) for infectious otitis externa drugs for topical use in dogs.