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Posted On: 10/23/2020 2:57:18 PM
Post# of 148908
mtroung34
I get a popup on marketwatch that wants me to log in or pay. In any event, I saw some additional info about Remdesivir in case someone wants to do more digging.
The FDA put out a 5 page Q&A updated on 10/22/20 entitled
"Frequently Asked Questions for Veklury (remdesivir)".
Here is an excerpt:
Q. What is the difference between an Emergency Use Authorization (EUA) and an FDA approval?
A. Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), the FDA may, pursuant to a determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or lifethreatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as
FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA will consider whether a sponsor is working towards seeking FDA approval when evaluating the continued appropriateness of the
EUA.
FDA approves New Drug Applications (NDAs) under section 505(c) of the FD&C Act. The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical that is not a biologic1 for sale and marketing in the U.S. In approving an NDA, FDA reviewers must determine, among other things, that the drug is safe and effective for its labeled use(s), and that the benefits of the drug outweigh the risks; that the drug's labeling (package insert) is appropriate; and that the methods
used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity. The statutory standard for an NDA approval requires substantial evidence of effectiveness, which is a higher level of evidence of effectiveness than required for an EUA.
Q. Is Veklury (remdesivir) approved by the FDA to treat COVID-19?
A. On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
https://www.fda.gov/media/137574/download
Here is the 36 page fact sheet issued by the FDA
https://www.fda.gov/media/137566/download
Here is the 25 page prescribing info issued by Gilead
https://www.gilead.com/-/media/files/pdfs/med...C8507B7299
I get a popup on marketwatch that wants me to log in or pay. In any event, I saw some additional info about Remdesivir in case someone wants to do more digging.
The FDA put out a 5 page Q&A updated on 10/22/20 entitled
"Frequently Asked Questions for Veklury (remdesivir)".
Here is an excerpt:
Q. What is the difference between an Emergency Use Authorization (EUA) and an FDA approval?
A. Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), the FDA may, pursuant to a determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or lifethreatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as
FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA will consider whether a sponsor is working towards seeking FDA approval when evaluating the continued appropriateness of the
EUA.
FDA approves New Drug Applications (NDAs) under section 505(c) of the FD&C Act. The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical that is not a biologic1 for sale and marketing in the U.S. In approving an NDA, FDA reviewers must determine, among other things, that the drug is safe and effective for its labeled use(s), and that the benefits of the drug outweigh the risks; that the drug's labeling (package insert) is appropriate; and that the methods
used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity. The statutory standard for an NDA approval requires substantial evidence of effectiveness, which is a higher level of evidence of effectiveness than required for an EUA.
Q. Is Veklury (remdesivir) approved by the FDA to treat COVID-19?
A. On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
https://www.fda.gov/media/137574/download
Here is the 36 page fact sheet issued by the FDA
https://www.fda.gov/media/137566/download
Here is the 25 page prescribing info issued by Gilead
https://www.gilead.com/-/media/files/pdfs/med...C8507B7299
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