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Clinical Pharmacology Considerations for Peptide Drug Products

Clinical Pharmacology Considerations for Peptide Drug Products

Drug administrationGuidance issuing officeSubmit commentsDrug evaluationPharmacology considerationsPeptide drug products

Endogenous Cushing s Syndrome: Developing Drugs for Treatment

Endogenous Cushing s Syndrome: Developing Drugs for Treatment
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Drug administrationGuidance issuing officeSubmit commentsDrug evaluationDeveloping drugsGeneral endocrinology

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

This guidance proposes 4 best practices for choosing a predicate device to support a 510(k) submission.

Guidance issuing officeDrug administrationRadiological healthSubmit commentsBiologics evaluation

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission.

Drug administrationGuidance issuing officeRadiological healthSubmit commentsBiologics evaluationEvaluating substantial equivalencePremarket notifications

Evidentiary Expectations for 510(k) Implant Devices

This guidance serves as a primary resource to provide clarity regarding expectations for performance data for implanted medical devices.

Radiological healthGuidance issuing officeDrug administrationSubmit commentsBiologics evaluation

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