What to expect from FDA? FDA could literally pull
Post# of 591
(Total Views: 103)
Posted On: 02/28/2025 10:09:23 AM
What to expect from FDA? FDA could literally pull the plug! Lets hope because of RFK the new director politics or big pharma will not have any influence!!
The FDA has substantial discretion in the PMA approval process. The FDA can limit or deny approval of a product for many reasons, including, but not limited, to:
a product may not be deemed to be safe and effective; ·
the FDA may not find the data from clinical trials and preclinical studies sufficient;
the opportunity for bias in the clinical trials as a result of the open-label design may not be adequately handled and may cause our trial to fail;
the FDA may not approve suppliers’ processes or facilities; or
the FDA may change its approval policies or adopt new regulations.
In addition, regulatory clearance or approval by the FDA does not ensure registration, clearance, approval, or certification by comparable foreign regulatory authorities. Complying with foreign regulatory requirements, including obtaining registrations, clearances, approvals, or certifications, can be expensive and time consuming, and we may not receive regulatory clearances, approvals, or certifications in each country or region in which we plan to market our products or we may be unable to do so on a timely basis. In turn, this could limit our ability to expand into international markets, which could have a material adverse effect on our business, financial condition, and results of operations.
The FDA has substantial discretion in the PMA approval process. The FDA can limit or deny approval of a product for many reasons, including, but not limited, to:
a product may not be deemed to be safe and effective; ·
the FDA may not find the data from clinical trials and preclinical studies sufficient;
the opportunity for bias in the clinical trials as a result of the open-label design may not be adequately handled and may cause our trial to fail;
the FDA may not approve suppliers’ processes or facilities; or
the FDA may change its approval policies or adopt new regulations.
In addition, regulatory clearance or approval by the FDA does not ensure registration, clearance, approval, or certification by comparable foreign regulatory authorities. Complying with foreign regulatory requirements, including obtaining registrations, clearances, approvals, or certifications, can be expensive and time consuming, and we may not receive regulatory clearances, approvals, or certifications in each country or region in which we plan to market our products or we may be unable to do so on a timely basis. In turn, this could limit our ability to expand into international markets, which could have a material adverse effect on our business, financial condition, and results of operations.
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