Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol. This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. During the […]
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 blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s […]
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 Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such […]
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 Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). FDA is committed to providing timely guidance to support the response to COVID-19. The recommendations described […]
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 regulatory review expectations for certain limited modifications affecting the safety and effectiveness of a device required to have an approved PMA or the safety and probable benefit of a device required […]
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 content of postapproval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications […]
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 section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub. L. No. […]
COVID-19 Developing Drugs and Biological Products for Treatment or Prevention
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.” The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological […]
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, the guidance covers […]