Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical patient safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
Coupled with the PREP Act they can even protect drug companies by providing immunity from liability under EUA.
Knowing this you can see why the EUA is so important to drug developers. It will make the drug quicker to bring to market, not held to the same patient safety standards, manufacturing standards, immunity from any liabilities associated with the drug and available without a prescription. It is a massive giveaway and likely increases the profitability of such a drug at least fourfold if not much, much more.
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical patient safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
Coupled with the PREP Act they can even protect drug companies by providing immunity from liability under EUA.
Knowing this you can see why the EUA is so important to drug developers. It will make the drug quicker to bring to market, not held to the same safety standards, immunity from any liabilities associated with the drug and available without a prescription. It is a massive giveaway and likely increases the profitability of such a drug at least fourfold if not much, much more.
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical patient safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
Coupled with the PREP Act they can even protect drug companies by providing immunity from liability under EUA.
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical patient safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
They can even protect drug companies from liability under EUA.
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical patient safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
They can even waive liability for the drug companies under EUA.
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical patient safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- "FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency."
EUA drugs do not have to comply with typical safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA."
Also: Your username is correct, they are pedos
Look up Emergency Use Authorization from the FDA and how much money is at stake as long as there are "no adequate, approved, and available alternatives." If hydroxychloroquine, azithromycin and zinc were to be classified as a treatment the EUA would not be available to any of the drug candidates being prepared for the Kung Flu. Not only that, EUAs have a host of benefits for the developer.
EUA drugs get easier approvals:
- The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.
EUA drugs are not held to typical standards in manufacture (CGMP - Current Good Manufacturing Practice):
- "FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs". Expects, not demands. They waive the typical requirements.
EUA drugs may not require a prescription:
- FDA may waive otherwise applicable prescription requirements, to the extent appropriate given the circumstances of an emergency
EUA drugs do not have to comply with typical safety standards, Risk Evaluation and Mitigation Strategy (REMS)
- "FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that would trigger an EUA"
Also: Your username is correct, they are pedos