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The 510(k) Program: Evaluating Substantial Equivalence In Premarket

FDA developed this document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions. The intent of …

Actived: Sunday Jun 26, 2022

Detail: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k

Data Integrity and Compliance With Drug CGMP Questions and …

(53 years ago) The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Data Integrity and Compliance With Drug CGMP: Questions and …

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ePublication (ePub)

(53 years ago) We have detected that you are using Internet Explorer, which is not supported by EPUB. Internet Explorer has been deprecated by Microsoft and does not support the advanced browser features required for EPUB to work properly.

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PDUFA REAUTHORIZATION PERFORMANCE GOALS AND …

(53 years ago) 4 I. ENSURING THE EFFECTIVENESS OF THE HUMAN DRUG REVIEW PROGRAM A. REVIEW PERFORMANCE GOALS 1. NDA/BLA Submissions and Resubmissions2 a. Review and act on 90 percent of standard NME NDA and ...

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Enhancing the Diversity of Clinical Trial Populations — Eligibility ...

(53 years ago) Nov 13, 2020 · GUIDANCE DOCUMENT. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry November 2020

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Testing and Labeling Medical Devices for Safety in the Magnetic ...

(53 years ago) May 19, 2021 · This guidance document provides recommendations on testing and labeling for safety and compatibility of medical devices in the Magnetic Resonance Environment.

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Safety | FDA

(53 years ago) The FDA's programs to monitor product safety: Recalls, market withdrawals, safety alerts, problem reporting systems, and postmarket monitoring systems, including MedWatch and the Sentinel Initiative.

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UDI formats by FDA-Accredited Issuing Agency

(53 years ago) Jan 27, 2017 · UDI formats by FDA-Accredited Issuing Agency Version 1.3: January 27, 2017 . FDA has accredited three organizations as . UDI …

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iHealth Labs, Inc.: iHealth COVID -19 Antigen Rapid Test 6 …

(53 years ago) Version April 27, 2022 . iHealth Labs, Inc.: iHealth COVID -19 Antigen Rapid Test . 6-month to 9-month self-life extension granted by the FDA March 29, 2022

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FDA Label Search

(53 years ago) IMPORTANT DISCLAIMER. Please be aware of the following when using information from this Web site: The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted …

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A Risk-Based Approach to Monitoring of Clinical Investigations ...

(53 years ago) Guidance for Industry - A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers

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Cybersecurity in Medical Devices: Quality Systems and Premarket

(53 years ago) Apr 08, 2022 · The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices ...

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FDA Purplebook

(53 years ago) You need to enable JavaScript to run this app. FDA Purplebook. You need to enable JavaScript to run this app.

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How Consumers Can Report an Adverse Event or Serious Problem …

(53 years ago) Report serious adverse events for human medical products, including potential or actual product use errors, product quality problems, and therapeutic failure.

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Fast Track, Breakthrough Therapy, Accelerated Approval, …

(53 years ago) Speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing ...

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News & Events | FDA

(53 years ago) FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public.

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Bioavailability and Bioequivalence Studies Submitted in NDAs …

(53 years ago) Apr 29, 2020 · The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General ...

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Open-source APIs

(53 years ago) Oct 13, 2020 · View Community Apps. openFDA features an open user community for sharing open source code, examples, and ideas.

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Current Good Manufacturing Practices (CGMPs) for Food and …

(53 years ago) Following Current Good Manufacturing Practices (CGMPs) help to ensure the safety of food. CGMP regulations generally address matters including …

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Adaptive Design Clinical Trials for Drugs and Biologics …

(53 years ago) This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or ...

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Understanding Unapproved Use of Approved Drugs "Off Label"

(53 years ago) The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

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Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors | FDA

(53 years ago) SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

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Information about Taking Ibuprofen and Aspirin Together | FDA

(53 years ago) Taking aspirin to help prevent a heart attack? If so, talk to your doctor before taking ibuprofen at the same time. Taking ibuprofen at the same time, for pain relief, may interfere with the ...

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Drug and Biologic Approval and IND Activity Reports | FDA

(53 years ago) Oct 17, 2019 · The list below includes links to Center for Drug Evaluation and Research new drug and biologic approval reports. These reports contain information on new drug application (NDA), biologic license ...

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Nonsteroidal Anti-inflammatory Drugs (NSAIDs) | FDA

(53 years ago) Dec 31, 2020 · Nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over-the-counter (OTC). They are used to relieve fever and pain, such as those associated with headaches, colds, flu ...

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Patient-Reported Outcome Measures: Use in Medical Product Development ...

(53 years ago) This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to …

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Content of Premarket Submissions for Management of …

(53 years ago) The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and ...

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Good Pharmacovigilance Practices and Pharmacoepidemiologic …

(53 years ago) This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products ...

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Purple Book: Lists of Licensed Biological Products

(53 years ago) Aug 03, 2020 · The Purple Book includes the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351 ...

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Quality Systems Approach to Pharmaceutical Current Good Manufacturing ...

(53 years ago) This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the …

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LOGIN

(53 years ago) **WARNING** This is a United States Food and Drug Administration computer system which may be accessed and used by authorized users only. Individuals using this computer system without authority, or in excess of their authority, are subject to criminal, civil, and/or administrative action.

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WebTrader

(53 years ago) User Name: Password: I accept the Terms of Service.

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Retail Food Protection: Employee Health and Personal Hygiene Handbook

(53 years ago) Mar 07, 2022 · The handbook includes best practices and behaviors that can help prevent food employees from spreading bacteria and viruses, such as Salmonella and norovirus, that cause foodborne illness.

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Sterile Drug Products Produced by Aseptic Processing — …

(53 years ago) This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l …

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FDA Adverse Event Reporting System

(53 years ago) Updates. Frequency Quarterly. Lag in data updates 3 months. Time period. Earliest data Q1 2014Q1 2014

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Current Good Manufacturing Practices (CGMPs) for Dietary …

(53 years ago) Final Rule: Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements. Federal Register for the Final Rule - …

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Coronavirus Disease 2019 (COVID-19) Emergency Use …

(53 years ago) Nov 15, 2021 · On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a ...

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UNII - Archive

(53 years ago) May 09, 2022 · Substance Registration System. Last Updated on May 9, 2022.Please contact [email protected] to receive email notification of updates to this page.

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FDA Adverse Event Reporting System (FAERS): Latest Quarterly …

(53 years ago) FDA Adverse Event Reporting System (FAERS) - Quarterly Data Extract (QDE): The Quarterly Data Extract files, contain raw data extracted from the …

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Medical Foods Guidance Documents & Regulatory Information

(53 years ago) Jan 25, 2022 · The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of ...

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Adderall and Adderall XR (amphetamines) Information | FDA

(53 years ago) The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

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Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent

(53 years ago) Feb 15, 2022 · STN: 103914 Proper Name: Influenza Vaccine Tradename: Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere Manufacturer ...

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