Posted 23 July 2020 | By
A new proposed rule issued by the US Food and Drug Administration (FDA) provides sponsors and manufacturers detailed guidance on the annual summary reporting required of them under the Right to Try Act.
“The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, in announcing the publication of the proposed rule. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.”
The proposed rule would have manufacturers and sponsors of eligible investigational drugs submit an annual summary of any use of the drug as supplied under section 561B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The federal statute requires that annual summary reporting include the uses for which the drugs were supplied, the number of doses supplied, how many patients were treated, and any known serious adverse events occurring from use of the investigational drug.
FDA includes detailed guidance in the rule about how to structure annual reporting of each of the statutorily required data categories, including a suggested tabular summary and ways to maintain patient privacy. Patients’ identifying information should not be included in the submission, noted FDA.
In its description of the proposed rule, FDA clarifies that the Right to Try Act annual summary reporting will be completed separately from the annual reporting already required for investigational drug applications under 21 CFR 312.33.
FDA explained that several factors went into this decision: “We concluded that a separate process will help to ensure that information about the use of eligible investigational drugs under the Right to Try Act is identified by FDA,” wrote the agency. “We believe sponsors who provide drugs under the Right to Try Act will appreciate this effort to keep the information separate. This approach will also enhance FDA’s ability to quickly identify and compile this information so we can post the required annual summary of these reports.”
The deadline for submission of the annual summary would be 31 March for the preceding calendar year. The first annual summary would include all Right to Try Act use of an investigational drug from May 30, 2018, when the act was enacted, through the effective date of the final rule.
In announcing the proposed rule, FDA explained that the Right to Try Act is also known as the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017. The Act “provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments,” explained the agency. “Ultimately, the sponsor or manufacturer who is developing the drug or biologic, not the FDA, is responsible for determining whether to make their product available to patients who qualify for access under the Right to Try Act.”
FDA
“The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, in announcing the publication of the proposed rule. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.”
The proposed rule would have manufacturers and sponsors of eligible investigational drugs submit an annual summary of any use of the drug as supplied under section 561B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The federal statute requires that annual summary reporting include the uses for which the drugs were supplied, the number of doses supplied, how many patients were treated, and any known serious adverse events occurring from use of the investigational drug.
FDA includes detailed guidance in the rule about how to structure annual reporting of each of the statutorily required data categories, including a suggested tabular summary and ways to maintain patient privacy. Patients’ identifying information should not be included in the submission, noted FDA.
In its description of the proposed rule, FDA clarifies that the Right to Try Act annual summary reporting will be completed separately from the annual reporting already required for investigational drug applications under 21 CFR 312.33.
FDA explained that several factors went into this decision: “We concluded that a separate process will help to ensure that information about the use of eligible investigational drugs under the Right to Try Act is identified by FDA,” wrote the agency. “We believe sponsors who provide drugs under the Right to Try Act will appreciate this effort to keep the information separate. This approach will also enhance FDA’s ability to quickly identify and compile this information so we can post the required annual summary of these reports.”
The deadline for submission of the annual summary would be 31 March for the preceding calendar year. The first annual summary would include all Right to Try Act use of an investigational drug from May 30, 2018, when the act was enacted, through the effective date of the final rule.
In announcing the proposed rule, FDA explained that the Right to Try Act is also known as the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017. The Act “provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments,” explained the agency. “Ultimately, the sponsor or manufacturer who is developing the drug or biologic, not the FDA, is responsible for determining whether to make their product available to patients who qualify for access under the Right to Try Act.”
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July 24, 2020 at 04:26AM
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FDA proposes reporting rule for Right to Try Act - Regulatory Focus
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