Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements guidance addresses certain requirements that apply to…
Read more →Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for…
Read more →Development and Licensure of Vaccines to Prevent COVID-19
Development and Licensure of Vaccines to Prevent COVID-19 guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of…
Read more →Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions
Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions guidance to provide clarification on its policies and…
Read more →COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry guidance to collate recommendations for appropriate reporting category and the…
Read more →Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act proposed guidance to address…
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