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…
Read more →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…
Read more →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…
Read more →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…
Read more →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…
Read more →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…
Read more →