U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on February 3, 2025 - 22:38 GMT

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human ...

Docket Number: FDA-2004-D-0366 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 19:55 GMT

Clinical Decision Support Software

Docket Number: FDA-2017-D-6569 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Section 3060(a) of the 21st Century Cures Act (Cures Act), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 19:54 GMT

Contents of a Complete Submission for the Evaluation of Proprietary Names

Docket Number: FDA-2008-D-0592 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes for industry the information that FDA uses to evaluate proposed proprietary names …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 17:04 GMT

Assessment of Abuse Potential of Drugs

Docket Number: FDA-2010-D-0026 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 14:19 GMT

Survey Methodologies to Assess REMS Goals That Relate to Knowledge

Docket Number: FDA-2018-D-4629 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to industry on conducting risk evaluation and 17 mitigation …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 14:19 GMT

M4E(R2): The CTD – Efficacy

Docket Number: FDA-2015-D-3235 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This is one in a series of guidances that provide recommendations for applicants preparing the Common …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 09:42 GMT

Volume Limits for Automated Collection of Source Plasma

Docket Number: FDA-2013-S-0613 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research The increased number of automated plasma collection devices with varying capacities for tailoring each collection to the specific donor has …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 06:53 GMT

Preclinical Assessment of Investigational Cellular and Gene Therapy Products

Docket Number: FDA-2012-D-1038 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue and Gene Therapies (OCTGT) is issuing this guidance to provide …

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Published on February 3, 2025 - 06:53 GMT

Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for ...

Docket Number: FDA-2006-D-0223 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA, are providing you, manufacturers of viral vaccines, guidance for the characterization and qualification of cell substrates, viral seeds, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2025 - 06:53 GMT

Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New ...

Docket Number: FDA-2008-D-0206 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance document provides to you, sponsors of a human gene therapy investigational new drug application (IND), recommendations on the …

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Published on February 3, 2025 - 06:52 GMT

How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)

Docket Number: FDA-2022-D-0487 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance for industry has been developed to clarify what information should be obtained before an individual case of an adverse experience …

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Published on February 3, 2025 - 04:11 GMT

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) ...

Docket Number: FDA-2015-D-0309 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide establishments1 that manufacture human cells, tissues, and cellular and tissue-based products (HCT/ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 1, 2025 - 01:31 GMT

Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To ...

Summary Company Announcement Date: January 31, 2025 FDA Publish Date: January 31, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential choking hazard for babies and young children Company …

Distribution channels: Food & Beverage Industry

Published on February 1, 2025 - 00:34 GMT

Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 31, 2025 - 23:56 GMT

Human Gene Therapy for Hemophilia

Docket Number: FDA 2018-D-2238 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance provides recommendations to sponsors developing human gene therapy (GT) products for the treatment of hemophilia including clinical …

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Published on January 31, 2025 - 21:18 GMT

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

Docket Number: FDA-1999-D-0063 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to sponsors and applicants who plan to conduct studies to assess …

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Published on January 31, 2025 - 21:18 GMT

S7A Safety Pharmacology Studies for Human Pharmaceuticals

Docket Number: FDA-2000-D-0274 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance was developed to help protect clinical trial participants and patients receiving marketed …

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Published on January 31, 2025 - 20:40 GMT

Evaluation of Sex Differences in Clinical Investigations

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice FDA Guideline On July 22, 1993, the FDA published the Guideline for the Study and Evaluation …

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Published on January 31, 2025 - 20:40 GMT

Premarketing Risk Assessment

Docket Number: FDA-2004-D-0121 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document provides guidance to industry on good risk assessment practices during the development of …

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Published on January 31, 2025 - 20:40 GMT

Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Class II Special Controls Guidance Document for Industry ...

PDF Printer Version Document issued on: October 30, 2003 For questions regarding this document contact Sally Hojvat Ph.D., Division of Microbiology Devices at 301-796-5455 or by e-mail: sally.hojvat@fda.hhs.gov. U.S. Department of Health and Human …

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