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September 18, 2023
Regulatory Considerations for Prescription Drug Use-Related Software
September 15, 2023
Labeling for Biosimilar and Interchangeable Biosimilar Products
September 14, 2023
Draft guidance provides recommendations for non-clinical testing to support premarket submissions for devices with indications associated with weight loss.
September 8, 2023
Clinical Pharmacology Considerations for Peptide Drug Products
September 6, 2023
This guidance proposes 4 best practices for choosing a predicate device to support a 510(k) submission.
September 6, 2023
This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission.
September 6, 2023
This guidance serves as a primary resource to provide clarity regarding expectations for performance data for implanted medical devices.
September 1, 2023
Post-Warning Letter Meetings Under GDUFA
August 10, 2023
Classification Categories for Certain Supplements Under BsUFA III