Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry guidance describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. This guidance also references several […]
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.
Certificates of Confidentiality Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff
Certificates of Confidentiality Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section […]
Clinical Investigator Administrative Actions – Disqualification
Clinical Investigator Administrative Actions – Disqualification Guidance document is intended to inform institutional review boards (IRBs), clinical investigators, and sponsors about the administrative action of disqualifying a clinical investigator from participating in studies involving investigational new drugs (including biologics) or devices. FDA may disqualify a clinical investigator from receiving investigational drugs (including biologics) and devices […]
Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Decentralized Clinical Trials for Drugs, Biological Products, and Devices draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other […]
Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors
Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent […]
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 […]