“Sponsors and applicants submitting or holding INDs, NDAs, or BLAs are subject to FDA requirements for submitting data to the FDA that are relevant to drug safety and effectiveness. When finalized, this new guidance will replace final guidance for industry that FDA published in 2005. The guidance, issued on 16 March 2023, also provides recommendations to sponsors on the format and level of detail for reporting pharmacogenomic data submissions, which will vary based on how the genomic biomarkers are used and the potential risks. The email address will appear and the button will change from Link to Unlink.The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory submissions for investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs).
Once your account gets authenticated, you will be redirected to the Genius™ profile setting page where you can now see that your account has been linked.Enter your email address and password to authenticate your account.You will see the login page as below for Google and LinkedIn respectively.Click the Link button next to the icon of your preferred SSO option. Genius™ will allow you to use a single sign-on option for Google and LinkedIn.
On the right hand side you can see an option Login Using – Google, LinkedIn or your organisation SSO/SAML Login.Click on Settings button will automatically navigate you to the Profile section.
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