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 […]
Human Gene Therapy Products Incorporating Human Genome Editing
Human Gene Therapy Products Incorporating Human Genome Editing guidance the FDA, are providing recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, this guidance provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application in order to assess the safety and quality […]
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products. In this guidance, we, FDA, provide CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design. Recommendations specific to […]
Takeda Came up with Budesonide new formulation
Takeda came up with the Budesonide new formulation which is Oral suspension which is indicated for the Hypercorticism and Adrenal axis syndrome along with that in Immunosuppression and increased risk of infection. For more information see the pdf consisting of FDA label.
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments document provides current specifications for submitting individual case safety reports (ICSRs) and ICSR attachments in electronic form. The specifications apply to electronic submission of ICSRs for drug and biological products, studied under an investigational new drug application (IND); ICSRs from bioavailability/bioequivalence (BA/BE) studies conducted without […]