Recently Posted Guidance Documents from the FDA & CDRH New Update

Guidance Documents

7/26/2019 – Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry
7/23/2019 – Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry
7/22/2019 – Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff

CDRH Update

Weight-Loss and Weight-Management Devices (Updated)

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