Jobs in Oncology/Hematology
FDA’s Office of Hematology Oncology Products is recruiting Medical Oncologists to serve in the dynamic, highly challenging, and innovative atmosphere…
Drug Trials Snapshots
Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort…
Institutional Review Boards Frequently Asked Questions
IRB Information Sheet – Frequently Asked Questions
Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
Tissue Agnostic Drug Development in Oncology
This guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may…
USPS lifts brief suspension of inbound China, Hong Kong packages
The agency said it’s working with Customs and Border Protection to establish a better collection method for additional tariffs placed…
Institutional Review Board (IRB) Written Procedures
Guidance for institutions and IRBs on IRB written procedures
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request…
Evaluation of Sex Differences in Clinical Investigations
Evaluation of Sex Differences in Clinical Investigations – IRB Information Sheet
Summarized changes to Section 308 of HIPAA Security
Yesterday, I gave you the side-by-side comparison of changes to Section 308 in the new HIPAA Security rule. Today, I…