New FDA Draft Guidance Clarifies Standards for Submission of HIV-1 Virology Resistance Data

Draft, Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency, Guidance for Submitting HIV-1 Resistance DataIn June 2006 the FDA released its Guidance for Industry: Antiviral Product Development – Conducting and Submitting Virology Studies to the Agency available here: http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0183-gdl0002-01.pdf. Since its release the FDA has developed three attachments (available here: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124470.htm) with the fourth, DRAFT Guidance for Submitting HIV-1 Resistance Data currently open for comment.

The purpose of this new draft guidance is to Continue reading

FDA releases draft guidance to outline standardized electronic study data format

When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading