ايف ڊي اي دستور ۽ استعمال ڪندڙ هدايتون

FDA AB7500 23A بيڪٽيرياولوجيڪل تجزياتي هدايتون

نومبر 2، 2023

FDA AB7500 23A Bacteriological Analytical Important Information Isolation and Identification of Nontuberculous Mycobacteria Associated with Tattoo-related Skin Infections There have been several tattoo-related outbreaks of nontuberculous mycobacterial infection in the US in recent years. In response to the outbreaks, FDA…

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FDA ENSPRYNG Dosage en Spryng Injection Instruction Manual

آڪٽوبر 25، 2023

Instructions for Use ENSPRYNG® (en-spryng) (satralizumab-mwge) Injection Read this Instructions for Use before you start using your prefilled syringe and each time you get a refill. There may be new information. This information does not take the place of talking…

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FDA Premarket Tobacco Product Application User Guide

آڪٽوبر 4، 2023

يو ايس فوڊ اينڊ ڊرگ ايڊمنسٽريشن سينٽر فار ٽوبيڪو پراڊڪٽس (سي ٽي پي) پراڊڪٽ فارم ويليڊيٽر ٽول يوزر گائيڊ ڊاڪيومينٽ ورزن نمبر: 1 سيپٽمبر 2023 تعارف ايف ڊي اي سينٽر فار ٽوبيڪو پراڊڪٽس (سي ٽي پي) جي ضرورت آهي ته پري مارڪيٽ ٽوبيڪو پراڊڪٽ ايپليڪيشن (پي ايم ٽي اي) ۾ سائنسي…

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FDA Advanceing Health Medical Devices Instruction Manual

سيپٽمبر 3، 2023

EXECUTIVE SUMMARY FOR THE PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING Advancing Health Equity in Medical Devices Disclaimer: This Executive Summary is for discussion purposes only and does not represent draft or final guidance. It is not intended to propose or implement…

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FDA ڊپارٽمينٽ آف صحت ۽ انساني خدمتن جون هدايتون

آگسٽ 29، 2023

FDA ڊپارٽمينٽ آف هيلٿ اينڊ هيومن سروسز هدايتون عنوان 21 خالي جاين جو اعلان ڊپارٽمينٽ آف هيلٿ اينڊ هيومن سروسز (HHS) فوڊ اينڊ ڊرگ ايڊمنسٽريشن (ايف ڊي اي) سينٽر فار بايولوجيز ايويوليشن اينڊ ريسرچ (سي بي اي آر) آفيس آف ويڪسين ريسرچ اينڊ ريسرچview (OVRR) Division of…

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FDA Optilume BPH ڪيٿيٽر سسٽم ھدايت وارو دستور

آگسٽ 12، 2023

FDA Optilume BPH Catheter System Product Information The Optilume BPH Catheter System is a medical device designed for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in patients 50 years of age or older. It is…

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FDA SurVeil Drug-coated Baloon User Guide

آگسٽ 12، 2023

FDA SurVeil Drug-Coated Balloon Product Information The SurVeilTM Drug-Coated Balloon is a medical device authorized by Federal (U.S.) law for the treatment of peripheral artery disease (PAD). It is specifically designed to treat femoral or popliteal artery stenosis, which is…

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FDA عنوان 21 خالي جاين جي اعلان جون هدايتون

آگسٽ 5، 2023

FDA Title 21 Vacancy Announcement Introduction The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds…

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FDA Swab-N-Go HomeTest COVID-19 Ag Rapid Diagnostic Test for detection of SARS-CoV-2 Antigen Instruction Manual

24 جولاءِ 2023ع

FDA Swab-N-Go HomeTest COVID-19 Ag Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Instruction Manual INTENDED USE The Swab-N-Go Home Test COVID-19 Ag is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. This…

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FDA Breast Implants جي هدايتون

22 جولاءِ 2023ع

FDA Breast Implants Product Information: Breast Implants Breast implants are medical devices that are used for breast augmentation, reconstruction, or revision surgery. Before undergoing any breast implant surgery, it is crucial to carefully consider several important factors. The U.S. Food and…

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