mia_rose_painter
Wed Nov 06 2024
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5 answers
1374
Is Lucky Iron Fish FDA approved?
The user wants to know if Lucky Iron Fish, a product designed to help with iron deficiency, has been approved by the FDA.
Martino
Mon Sep 23 2024
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6 answers
754
How much does it cost to get FDA approval?
I'm curious to know, how much does it typically cost a company to secure FDA approval for a new drug or medical device? Is there a standard fee structure, or does it vary based on factors such as the complexity of the product or the length of the approval process? And are there any potential hidden costs or expenses that companies should be aware of when budgeting for this critical step in bringing a product to market?
CryptoMaven
Thu Sep 05 2024
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5 answers
1020
Is PDUFA the same as FDA approval?
Excuse me, I've been doing some research on the drug development process and came across the term PDUFA. Could you please clarify for me if PDUFA is synonymous with FDA approval? I understand that the FDA oversees the approval of drugs in the US, but I'm a bit confused about the role PDUFA plays in this process. Could you elaborate on the difference, if any, and how PDUFA fits into the overall framework of FDA drug approvals? Thank you in advance for your clarification.
