This meeting provided an opportunity to discuss ways in which FDA is enhancing the generic drug program by improving the efficiency of application review and inspections within the current regulatory structure. FDA also discussed other potential efficiency-enhancing mechanisms such as greater transparency of inspection information and changes to inspections such as third party foreign government inspections and placement of inspectors in country and ways to determine the value of such changes.
FDA also outlined needs for improved information technology, including databases related to tracking facilities and cross referencing applications as appropriate.The Generic Pharmaceutical Association (GPHA) gave its suggestions on ways in which the FDA could improve efficiencies, many of which were in agreement with FDA’s, such as incentives for electronic application submission and increased transparency of inspections. Other suggestions included ways to address the backlog and adding conference calls to the review process.
To find more information about the meeting please click here: FDA: The Generic Pharmaceutical Association (GPHA) - Industry-FDA negotiations "incentives for electronic application submission
FDA also outlined needs for improved information technology, including databases related to tracking facilities and cross referencing applications as appropriate.The Generic Pharmaceutical Association (GPHA) gave its suggestions on ways in which the FDA could improve efficiencies, many of which were in agreement with FDA’s, such as incentives for electronic application submission and increased transparency of inspections. Other suggestions included ways to address the backlog and adding conference calls to the review process.
To find more information about the meeting please click here: FDA: The Generic Pharmaceutical Association (GPHA) - Industry-FDA negotiations "incentives for electronic application submission
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