(Total Views: 462)
Posted On: 11/15/2025 9:58:23 AM
Post# of 158792
Re: KenChowder #158473
No.
Accelerated approval is a different thing.
I have to head to work or would search the particulars again and make sure Im not using the incorrect term.
I will later if someone else doesnt.
I let AI do a quick summary
Accelerated approval requirements fda:
"The FDA's Accelerated Approval pathway is designed to bring drugs for serious or life-threatening conditions that fill an unmet medical need to market faster.
The primary requirements for FDA accelerated approval are:
Serious or Life-Threatening Condition: The drug must be intended to treat a serious or life-threatening illness (e.g., cancer, HIV/AIDS, heart failure).
Unmet Medical Need: The drug must provide a therapy where none exists, or a potential advantage over available therapies (e.g., superior effectiveness, avoidance of serious side effects, or a novel mechanism of action).
Effect on a Surrogate or Intermediate Endpoint: The approval is granted based on evidence that the drug affects a "surrogate endpoint" or an "intermediate clinical endpoint" that is considered reasonably likely to predict a real clinical benefit, rather than waiting for final clinical outcomes like extended survival.
Post-Marketing (Confirmatory) Trials: The manufacturer is required to conduct additional "adequate and well-controlled" Phase 4 clinical trials after approval to verify and describe the drug's actual clinical benefit.
Due Diligence in Confirmatory Trials: Sponsors must show due diligence in conducting these post-approval studies, and the FDA can require a study to be underway prior to granting approval in certain circumstances.
Potential for Withdrawal: The FDA retains the authority to withdraw approval if the confirmatory trials fail to verify the predicted clinical benefit or if the sponsor does not meet their post-marketing study obligations.
Accelerated approval is an important pathway for providing early access to promising new therapies for patients with serious conditions
Accelerated approval is a different thing.
I have to head to work or would search the particulars again and make sure Im not using the incorrect term.
I will later if someone else doesnt.
I let AI do a quick summary
Accelerated approval requirements fda:
"The FDA's Accelerated Approval pathway is designed to bring drugs for serious or life-threatening conditions that fill an unmet medical need to market faster.
The primary requirements for FDA accelerated approval are:
Serious or Life-Threatening Condition: The drug must be intended to treat a serious or life-threatening illness (e.g., cancer, HIV/AIDS, heart failure).
Unmet Medical Need: The drug must provide a therapy where none exists, or a potential advantage over available therapies (e.g., superior effectiveness, avoidance of serious side effects, or a novel mechanism of action).
Effect on a Surrogate or Intermediate Endpoint: The approval is granted based on evidence that the drug affects a "surrogate endpoint" or an "intermediate clinical endpoint" that is considered reasonably likely to predict a real clinical benefit, rather than waiting for final clinical outcomes like extended survival.
Post-Marketing (Confirmatory) Trials: The manufacturer is required to conduct additional "adequate and well-controlled" Phase 4 clinical trials after approval to verify and describe the drug's actual clinical benefit.
Due Diligence in Confirmatory Trials: Sponsors must show due diligence in conducting these post-approval studies, and the FDA can require a study to be underway prior to granting approval in certain circumstances.
Potential for Withdrawal: The FDA retains the authority to withdraw approval if the confirmatory trials fail to verify the predicted clinical benefit or if the sponsor does not meet their post-marketing study obligations.
Accelerated approval is an important pathway for providing early access to promising new therapies for patients with serious conditions
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