Big Data Steering Group (BDSG): 2023 report
Providing Submissions in Electronic Format Post marketing Safety Reports
Providing Submissions in Electronic Format Post marketing Safety Reports guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Assessing the Effects of Food on Drugs in INDs and NDAs Clinical Pharmacology Considerations
Assessing the Effects of Food on Drugs in INDs and NDAs Clinical Pharmacology Considerations this guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 […]
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations. This guidance […]
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) […]
Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers
Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and S7B Nonclinical Evaluation of the Potential for Delayed […]
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that contain RWD/RWE intended to support a regulatory decision regarding product safety and/or effectiveness.
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for the development of drugs to […]
REMS Document Technical Conformance Guide
REMS Document Technical Conformance Guide provides updated, detailed instructions on the format of a REMS Document, along with standardized language that describes common REMS requirements for applicants to use whenever possible, to help ensure consistency and facilitate efficient review of the REMS Document. This Guide supports submission of a REMS Document in Structured Product Labeling […]