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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 priručnici

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Upute za injekcije FDA Midazolama

Upute za injekcije FDA Midazolama

10. oktobar 2024
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 Test uputstva

FDA K240280 Nano Check RSV Test uputstva

30. septembra 2024
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 Upute sjedišta za mjernu poštu

FDA h:2250.1 Upute sjedišta za mjernu poštu

23. avgusta 2024
FDA h2250.1 Metered Mail Svrha Ovaj vodič postavlja zahtjeve za mjerenje odlazne administrativne pošte na lokacijama sjedišta kako bi se unaprijed platilo USPS postage costs. Background In order…
FDA CFSAN modul za podnošenje korisničkog vodiča

FDA CFSAN modul za podnošenje korisničkog vodiča

15. avgusta 2024
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 Uputstva za hranu i lijekove

FDA 2004-N-0451 Uputstva za hranu i lijekove

31. jul 2024
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 Viramune tablete za oralnu suspenziju Upute

FDA Viramune tablete za oralnu suspenziju Upute

6. jul 2024
FDA Viramune Oral Suspension Tablet Instructions Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information does…
FDA Zyprexa olanzapin tablete Upute

FDA Zyprexa olanzapin tablete Upute

6. jul 2024
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…
Zakon o modernizaciji sigurnosti hrane FDA (FSMA)view

Zakon o modernizaciji sigurnosti hrane FDA (FSMA)view

Fact Sheet
Gotovoview 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

Bioresearch Monitoring Technical Conformance Guide

vođenje
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…