Q – What is the latest information regarding New Animal Drug Application (NADA) submissions for drug listings (June 2014)?
A – Since last month, the FDA has revised the animal drug listing procedures to reverse their prior procedures regarding Active Pharmaceutical Ingredients (API’s). You may now submit your drug animal listings is exactly the same manner as your human drug listings. The only differences are that you use the NDA number for human drugs and NADA numbers for animal drugs. You also select the type of drug listing you are submitting… human or animal.
We recommend that you review and submit your human and animal drug listings to remove the “unapproved medical gas” statement from your online FDA drug listings. The following resources are available on the GAWDA.ORG website:
- An 18 minute recorded teleconference about how to remove the “unapproved medical gas” statement from your online FDA drug listings: http://www.aws.org/GAWDA/audio/Medical_Gas_Update_20140131.WAV
- Handouts and sample forms for the recorded teleconference: http://www.gawda.org/uploadedFiles/Site_Framework/Home_Page/FDA_Medical_Gas_Certification_Compliance_Alert_20140131.pdf
If you have any questions about this process or would like us to re-submit your drug listings, please contact firstname.lastname@example.org.