Capture.JPG

NextGen Collaboration Portal

New technology platform to allow industry to request FDA pre-ANDA meetings for complex generic drug products

  • initiate requests by uploading meeting request package
  • submit supporting documents e.g. presentation materials, additional information responses, post-meeting comments
  • minimize manual data entry
  • support GDUFA II performance goals.

LEARN


Image credit: FDA

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s