Cover Letter Attachments for Controlled Correspondences and ANDA Submissions
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDA) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, […]
Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of pharmaceuticals. Immunotoxicity is, for the purposes of this guidance, defined as unintended immunosuppression or stimulation (including hypersensitivity), which can include adverse effects of exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators.
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry guidance is intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design DDI studies, and determine how to communicate DDI study results and […]
Content of Premarket Submissions for Device Software Functions
Content of Premarket Submissions for Device Software Functions guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic […]
Guidance for Industry M7 R2 Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk
Guidance for Industry M7 R2 Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk. M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The guidance and supplemental documents are intended to harmonize the considerations for assessment and control of DNA reactive (mutagenic) […]
CDER Program for the Recognition of Voluntary Consensus Standards
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality guidance describes a program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. This program facilitates submissions by external stakeholders and FDA staff proposing voluntary consensus standards […]
Guidance on pediatric submission
The updated guidance of Pediatric submission of product. These guidelines suggest what things are necessary and what is not required.