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Posted On: 06/23/2020 7:27:06 AM
Post# of 148908
The new pathways act:
https://gallagher.house.gov/media/press-relea...thways-act
This will affect us very positively as Cancer is included. We are just about to start 10 Cancer trials !!! , take a read at the new path we have
I leave the sponsors (both sides of the aisle) speak::
Background:
The Food and Drug Administration (FDA) refers to the clinical trial process for prescription drugs in phases, i.e. Phase I, II and III. Early clinical trials (Phases I and II) establish and confirm safety while providing a considerable amount of data, often enough to statistically predict successful confirmatory trials. Confirmatory trials (Phase III) further test effectiveness and are the last step to a drug entering the market for patients’ use under a New Drug Application or Biologics License Application approval.
However, Phase III trials are extremely time-consuming and expensive, in some cases costing billions of dollars. If the FDA determines a drug doesn’t meet its standards of safety or effectiveness, small pharmaceuticals attempting to bring innovative drugs to market and compete with large drug companies can go bankrupt during Phase III trials.
The Promising Pathways Act would allow pharmaceutical companies to petition the FDA for provisional approval if the drug has cleared early stage clinical trials, already having proven safety and showing significant evidence of effectiveness. The company could then sell their drug at a market acceptable rate, give patients access to innovative treatments and compete with large, monopolistic pharmaceuticals to lower consumer cost.
https://gallagher.house.gov/media/press-relea...thways-act
This will affect us very positively as Cancer is included. We are just about to start 10 Cancer trials !!! , take a read at the new path we have
I leave the sponsors (both sides of the aisle) speak::
Quote:
This bill necessarily disrupts the status quo, prioritizes new strategies for treatment, and pushes the envelope for innovations in the effort to find cures
Quote:
The lengthy approval process and high costs associated with clinical trials delay companies from getting potentially lifesaving medication into the hands of those who need it most. The Promising Pathways Act would create another avenue of access, allowing patients to receive safe, effective medicine, even if they don’t qualify for the strict clinical trial requirements .
Quote:
The Promising Pathway Act would require the FDA to create a prioritized high-speed lane for evaluating drugs intended to treat, prevent, or diagnose serious or life-threatening diseases, including those that pose an epidemic or pandemic threat,
Quote:
I’m committed to finding cures for those suffering from rare and potentially fatal diseases, and this bill helps us fight for those with conditions like ALS and cancer while also strengthening our response to future pandemics.
Background:
The Food and Drug Administration (FDA) refers to the clinical trial process for prescription drugs in phases, i.e. Phase I, II and III. Early clinical trials (Phases I and II) establish and confirm safety while providing a considerable amount of data, often enough to statistically predict successful confirmatory trials. Confirmatory trials (Phase III) further test effectiveness and are the last step to a drug entering the market for patients’ use under a New Drug Application or Biologics License Application approval.
However, Phase III trials are extremely time-consuming and expensive, in some cases costing billions of dollars. If the FDA determines a drug doesn’t meet its standards of safety or effectiveness, small pharmaceuticals attempting to bring innovative drugs to market and compete with large drug companies can go bankrupt during Phase III trials.
The Promising Pathways Act would allow pharmaceutical companies to petition the FDA for provisional approval if the drug has cleared early stage clinical trials, already having proven safety and showing significant evidence of effectiveness. The company could then sell their drug at a market acceptable rate, give patients access to innovative treatments and compete with large, monopolistic pharmaceuticals to lower consumer cost.
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