FDA 3147 2017 free printable template
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REASON FOR REQUESTING VARIANCE Compliance with the limits of 21 CFR 1040. 11 c would restrict the intended use of the product because compliance would limit the output power to the extent that the desired effects would not be sufficiently visible Other or additional explanation Specify FORM FDA 3147 8/17 PREVIOUS EDITION IS OBSOLETE PSC Publishing Services 301 443-6740 EF PAGE 1 OF 4 PAGES 11. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration APPLICATION FOR A VARIANCE FROM...
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How to fill out FDA 3147
01
Obtain the FDA Form 3147 from the FDA website or relevant authority.
02
Read the instructions carefully to understand the purpose of the form.
03
Fill out the applicant's information, including name, address, and contact details.
04
Provide detailed information about the product, including its name, formulation, and intended use.
05
Include any necessary documentation or supporting materials that may be required.
06
Review the form for accuracy to ensure all information is correctly entered.
07
Sign and date the form as required.
08
Submit the completed form to the FDA through the specified submission method.
Who needs FDA 3147?
01
Individuals or organizations seeking to obtain permission to conduct studies or trials involving drugs or biologics.
02
Researchers or developers of new pharmaceuticals that require FDA oversight before proceeding.
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What is FDA 3147?
FDA 3147 is a form used by the U.S. Food and Drug Administration (FDA) to collect information related to drug and biological product notifications, often associated with drug contamination or manufacturing issues.
Who is required to file FDA 3147?
Pharmaceutical companies, manufacturers, and distributors of drugs and biological products are required to file FDA 3147 when they encounter relevant issues pertaining to product safety or quality.
How to fill out FDA 3147?
FDA 3147 should be filled out by providing detailed information about the product, the issue encountered, any actions taken, and other relevant data as specified in the form instructions. Ensuring all required fields are completed accurately is crucial.
What is the purpose of FDA 3147?
The purpose of FDA 3147 is to ensure that the FDA is informed about significant product issues that may affect public health, allowing the agency to take appropriate regulatory action and ensure drug safety.
What information must be reported on FDA 3147?
The information reported on FDA 3147 includes product identification, details of the issue, consequences of the problem, company contact information, and any corrective actions taken or planned.
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