Department of Health and Human Services August 1, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Vulvovaginal Candidiasis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for treating vulvovaginal candidiasis (VVC). This guidance incorporates the comments received for and finalizes the draft guidance for industry of the same name issued July 1, 2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the development of new drugs for the treatment of uncomplicated urinary tract infections. This guidance finalizes the draft guidance of the same name issued May 10, 2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E8(R1) General Considerations for Clinical Studies.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, the draft guidance provides an overview of the types of clinical studies that may be performed and data sources during the product's life cycle. The draft guidance is intended to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.'' This draft guidance is intended to assist sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements who are planning to conduct clinical studies in neonatal populations. The issuance of this draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products is stipulated under the FDA Reauthorization Act of 2017 (FDARA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.'' This draft guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)- compliant toxicology studies. When pathology peer review occurs as part of a nonclinical laboratory study conducted in compliance with GLP regulations, it should be well-documented. However, documentation practices during pathology peer review have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer (Q&A) draft guidance is intended to clarify FDA's recommendations concerning the management, conduct, and documentation of pathology peer review.