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FDA vadovai ir naudotojo vadovai

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more.

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FDA vadovai

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FDA midazolamo injekcijos instrukcijos

10 m. spalio 2024 d
FDA Midazolam Injection Product Information Specifications Product Name: Midazolam Autoinjector Manufacturer: Rafa Laboratories, Ltd. Address: 3 Zeev Lev, Har Hotzvim Jerusalem, 9777515 Israel Revision Date: 11/2023 Reference ID: 5026561 Product…

FDA K240280 Nano Check RSV testo instrukcijos

30 m. rugsėjo 2024 d
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Background Information: A 510(k) Number  K240280 B Applicant  Nano-Ditech Corporation C Proprietary and Established Names Nano-Check RSV Test D Regulatory Information Product Code(s) Classification Regulation Section…

FDA h:2250.1 Metered Mail būstinės instrukcijos

23 m. rugpjūčio 2024 d
FDA h2250.1 Matuojamo pašto paskirtis Šiame vadove nustatyti siunčiamo administracinio pašto matavimo reikalavimai būstinėse, siekiant iš anksto apmokėti USPS pos.tage costs. Background In order…

FDA CFSAN pateikimo modulio vartotojo vadovas

15 m. rugpjūčio 2024 d
FDA CFSAN Submission Module Product Information Specifications Product Name: CFSAN Online Submission Module (COSM) Availability: 24 hours, 7 days a week Developed for: Transmitting submissions to FDA's CFSAN Product Usage…

FDA 2004-N-0451 Maisto ir vaistų instrukcijos

31 m. liepos 2024 d
FDA 2004-N-0451 Food and Drug Specifications Product Name: Food and Drug Administration Modernization Act of 1997 Recognition List Number: 062 Agency: Food and Drug Administration, HHS Product Usage Instructions Registration…

FDA Zyprexa Olanzapine tabletės instrukcijos

6 m. liepos 2024 d
FDA Zyprexa Olanzapine Tablet Product Information Specifications: Product Name: ZYPREXA Generic Name: Olanzapine Form: Tablet, Orally Disintegrating Product Usage Instructions: Before starting ZYPREXA, read the Medication Guide provided with the…

FDA maisto saugos modernizavimo įstatymas (FSMA)view

Faktų lapas
ir baigtaview of the FDA Food Safety Modernization Act (FSMA) final rule on mitigation strategies to protect food against intentional adulteration, outlining key requirements, applicability, and resources for the food…

Bioresearch Monitoring Technical Conformance Guide

gaires
This guide provides FDA specifications, recommendations, and general considerations for preparing and submitting Bioresearch Monitoring (BIMO) clinical data in electronic format for new drug applications (NDAs) and biologics license applications…