M9 Biopharmaceutics Classification System Based Biowaivers
M9 Biopharmaceutics Classification System Based Biowaivers guidance is being provided by FDA. Two drug products containing the same drug substance or substances are considered bioequivalent if their bioavailabilities (rate and extent of drug absorption) after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo […]
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), […]
Providing Regulatory Submissions in Electronic Format Standardized Study Data
Providing Regulatory Submissions in Electronic Format Standardized Study Data guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, […]
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside […]
FDA Export Certification
FDA Export Certification guidance document is intended to provide a general description of Food and Drug Administration (FDA or the Agency) export certification to industry and foreign governments. Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal […]
Development of Anti Infective Drug Products for the Pediatric Population
Development of Anti Infective Drug Products for the Pediatric Population guidance is to provide general recommendations on the development of anti-infective drug products, including antibacterial, antifungal, and antiparasitic products, for the pediatric population. FDA encourages sponsors to discuss their initial pediatric study plans (iPSPs) for anti-infective drug products with the Agency early. In most instances, […]
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) is being guidance provided by the FDA. Nonalcoholic steatohepatitis (NASH) is a subcategory of nonalcoholic fatty liver disease (NAFLD). NASH carries a significant disease burden as it can progress to cirrhosis and liver failure and is associated with an increase […]
Principles of Premarket Pathways for Combination Products
Principles of Premarket Pathways for Combination Products amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews. FDA is publishing this guidance as part […]
Population Pharmacokinetics
Population Pharmacokinetics guidance is intended to assist sponsors and applicants of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and investigational new drugs (IND) applications in the application of population pharmacokinetic (PK) analysis. Population PK analysis is frequently used to guide drug development and inform recommendations on therapeutic individualization (e.g., […]