Overview:
If you are a Medical Device, Pharmaceutical or Biologic company that has unapproved Medical Device (IVD), or Drug or Biologic product in well advanced development stage, that has shown evidence in the diagnostic, treatment or prevention of Coronavirus, or approved product in different indications, that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.
What Are the Qualification Criteria for EUA?
To be considered for FDA EUA the medical product should meet the following four criteria:
Serious or Life-Threatening Disease or Condition
The product has the potential to diagnose, treat or prevent a Serious or Life-Threatening Disease or Condition under the public emergency situation.
Evidence of Effectiveness
The product has shown some evidence to prevent, diagnose, or treat serious or life-threatening diseases or conditions under Secretary’s declaration of emergency
Risk-Benefit Analysis
The product potential benefits, when used to diagnose, prevent, or treat the identified disease or condition, outweigh its known potential risks.
Such evidence, which could arise from a variety of sources, may include (but is not limited to):
- results of domestic and foreign clinical trials
- in vivo efficacy data from animal models
- in vitro data
No Alternatives
There are no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition.
What Information to Submit to FDA in the Request of EUA?
A request for an EUA should include the following information:
List of requirements | Description |
A description of the product and its intended use | § Identification of the serious or life-threatening disease or condition for which the product may be effective. § Where, when, and how the product is anticipated to be used. § The population(s) for which the product may be used |
A description of the product’s FDA approval status
| § Whether the product is unapproved or whether it is approved but the EUA is for an unapproved use. § Whether the product or intended use is under an investigational application (IND/IDE is in effect or has been submitted). § Whether the product is approved in a foreign country for either the proposed use or another use. § Information on the use of the medical product by either a foreign country or an international organization. |
Justification for the need for the product | § A justification for the need for the product, including identification of any approved alternative product(s) and their availability and adequacy for the proposed use, and the unmet need(s) the EUA would address. |
Safety Information
| Unapproved Uses of Approved Products If the new indication uses a similar dose, duration, route of administration, or mechanism of action, and the intended patient population is similar, to that for which the product is approved, the following information should be submitted: § The approved application, § If the new use poses a different risk to the patient population (e.g., suggesting the possibility of increased toxicity), information from relevant in vitro studies, animal toxicology studies, and (if available) human clinical data and experience must be provided to support such a use. |
Unapproved Products § Preclinical testing data, such as in vitro and animal toxicology data. § Human safety information from clinical trials and individual patient experience be provided, if available. § Data submitted in the request should attempt to link the likely exposure to the MCM to any relevant, existing preclinical data. Similarly, when animal data are used, sufficient information should be provided to link the results of these data to expected exposures to the MCMs related to the proposed use in humans. | |
Effectiveness Information
| § Product’s mechanism(s) of action to diagnose, treat, or prevent the disease or condition underlying the request. § For drugs, preclinical testing data, such as in vitro evidence of the effect of the product in preventing or reducing the toxicity of the specified agent. § Data on activity or effectiveness in animals that would contribute to understanding potential effects in humans, including but not limited to any animal efficacy studies available for products being developed under the Animal Rule. |
Risks and Benefits | § Discussion of risks and benefits, including available information concerning the threats posed by the CBRN agent(s) involved |
CMC Information | § Information on chemistry (as applicable), manufacturing, and controls. § a list of each site where the product, if authorized, is or would be manufactured, and the current CGMP status of the manufacturing site(s). § Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s). § Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s). |
Information (“fact sheets”) for healthcare providers administering the product | § Information comparable to an FDA-approved package insert or instructions for use; drafts of the “Fact Sheets” to be furnished to health care professionals or authorized dispensers and recipients of the product. |
List of requirements
Description
A description of the product and its intended use
§ Identification of the serious or life-threatening disease or condition for which the product may be effective.
§ Where, when, and how the product is anticipated to be used.
§ The population(s) for which the product may be used
A description of the product’s FDA approval status
§ Whether the product is unapproved or whether it is approved but the EUA is for an unapproved use.
§ Whether the product or intended use is under an investigational application (IND/IDE is in effect or has been submitted).
§ Whether the product is approved in a foreign country for either the proposed use or another use.
§ Information on the use of the medical product by either a foreign country or an international organization.
Justification for the need for the product
§ A justification for the need for the product, including identification of any approved alternative product(s) and their availability and adequacy for the proposed use, and the unmet need(s) the EUA would address.
Safety Information
Unapproved Uses of Approved Products
If the new indication uses a similar dose, duration, route of administration, or mechanism of action, and the intended patient population is similar, to that for which the product is approved, the following information should be submitted:
§ The approved application,
§ If the new use poses a different risk to the patient population (e.g., suggesting the possibility of increased toxicity), information from relevant in vitro studies, animal toxicology studies, and (if available) human clinical data and experience must be provided to support such a use.
Unapproved Products
§ Preclinical testing data, such as in vitro and animal toxicology data.
§ Human safety information from clinical trials and individual patient experience be provided, if available.
§ Data submitted in the request should attempt to link the likely exposure to the MCM to any relevant, existing preclinical data. Similarly, when animal data are used, sufficient information should be provided to link the results of these data to expected exposures to the MCMs related to the proposed use in humans.
Effectiveness Information
§ Product’s mechanism(s) of action to diagnose, treat, or prevent the disease or condition underlying the request.
§ For drugs, preclinical testing data, such as in vitro evidence of the effect of the product in preventing or reducing the toxicity of the specified agent.
§ Data on activity or effectiveness in animals that would contribute to understanding potential effects in humans, including but not limited to any animal efficacy studies available for products being developed under the Animal Rule.
Risks and Benefits
§ Discussion of risks and benefits, including available information concerning the threats posed by the CBRN agent(s) involved
CMC Information
§ Information on chemistry (as applicable), manufacturing, and controls.
§ a list of each site where the product, if authorized, is or would be manufactured, and the current CGMP status of the manufacturing site(s).
§ Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s).
§ Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s).
Information (“fact sheets”) for healthcare providers administering the product
§ Information comparable to an FDA-approved package insert or instructions for use; drafts of the “Fact Sheets” to be furnished to health care professionals or authorized dispensers and recipients of the product.
How Long it Takes to FDA to Review EUA?
For complete applications, FDA expediate the review of complete application and may approve the EUA within 15 days.
What is the Validity of EUA?
For unapproved products, FDA recommends that companies submit a formal IND or IDE with the appropriate information, so that they can pursue the formal process of their products approval in USA.
What are FDA Recommendations?
For unapproved products, FDA recommends that companies submit a formal IND or IDE with the appropriate information, so that they can pursue the formal process of their products approval in USA.
GRP’s FDA EUA experience:
Please contact Global Regulatory Partners at info@globalregulatorypartners.com to check your eligibility for FDA EUA program.
Resources:
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations and with minimum risk.