Jodi Scott

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Latest Posts › Healthcare

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FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for...more

2/22/2019 / Biologics , Biosimilars , Draft Guidance , FDARA , Food and Drug Administration (FDA) , Healthcare , Inspection Rights , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Public Health , Regulatory Agenda , Regulatory Oversight

FDA releases final guidance document on PMA manufacturing site change supplements

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

12/21/2018 / FDA Approval , Final Guidance , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Standards

A "cure" for combination products: 21st Century Cures Act mandates greater transparency of combination product designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more

1/25/2017 / 21st Century Cures Initiative , Appeals , Biologics , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight

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