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FDA Guidance for Industry: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions

The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, [...]

2019-12-30T17:30:35+00:0030.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.  We, FDA, recommend [...]

2019-12-30T17:25:47+00:0030.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics

This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes important principles for designing, [...]

2019-12-07T11:23:08+00:0007.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

The purpose of this guidance is to help sponsors design and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, this guidance describes the Food and Drug Administration’s (FDA’s) current thinking about the substance and scope of nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and marketing [...]

2019-10-10T22:16:47+00:0010.10.2019|Regulatory Affairs, Training|

FDA Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such [...]

2019-10-03T21:27:05+00:0003.10.2019|Regulatory Affairs, Training|

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]

FDA Guidance for Industry: Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate nonclinical program for the development of radiopharmaceuticals to treat cancer — also known as oncology therapeutic radiopharmaceuticals — and to provide recommendations for certain aspects of product labeling. For the purpose of this guidance, a therapeutic radiopharmaceutical [...]

2019-08-08T19:44:17+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: 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). In general, this guidance focuses only on treating VVC. This guidance does not discuss clinical development programs focused on preventing or reducing the recurrence of VVC. Sponsors should [...]

2019-08-08T19:39:09+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Bacterial Vaginosis: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for the treatment of bacterial vaginosis (BV). This guidance focuses on considerations that are specific to BV drug development. This guidance does not contain discussion of [...]

2019-08-08T19:35:42+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated urinary tract infections (uUTIs). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of [...]

2019-08-08T19:29:58+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Risk Evaluation and Mitigation Strategies: Modifications and Revisions

This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS. Specifically, this guidance provides information, as described in section 505-1(h) [...]

2019-07-15T20:38:35+00:0015.07.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect

This guidance describes the Food and Drug Administration’s (FDA, we, or the Agency) policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or [...]

2019-07-15T20:17:15+00:0015.07.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This guidance describes policies that FDA intends to use in evaluating bulk drug substances [...]

2019-06-18T20:20:08+00:0018.06.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: ANDA Submissions — Content and Format of Abbreviated New Drug Applications

This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance details the information that should be provided in each section of the common technical document (CTD) format for human [...]

2019-06-17T22:15:11+00:0017.06.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

The purpose of this guidance is to provide to sponsors nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products (including small molecules and monoclonal antibodies), regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the prevention of sexually acquired human [...]

2019-03-25T21:40:34+00:0025.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Pediatric HIV Infection: Drug Product Development for Treatment

The purpose of this guidance is to provide general recommendations on the development of antiretroviral (ARV) drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric (birth to younger than 18 years of age) patients. This guidance is intended to help sponsors understand when it is appropriate to initiate pediatric formulation development and to begin pediatric [...]

2019-03-25T21:31:38+00:0025.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Severely Debilitating or LifeThreatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

The purpose of this guidance is to assist sponsors in the design of nonclinical studies for the development of pharmaceuticals used to treat patients with severely debilitating or lifethreatening hematologic disorders (SDLTHDs). This guidance is intended to streamline the development of pharmaceuticals used to treat patients with SDLTHDs, other than cancer, while still protecting patients’ safety and avoiding [...]

2019-03-18T22:12:07+00:0019.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products

The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate the effectiveness of drug and biological products. Enrichment is the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is [...]

2019-03-18T21:39:05+00:0019.03.2019|Regulatory Affairs, Training|