FDA Compliance
Auditing
Terminology
QA Checklist
Grab Bag
100

This can never be included in an ad containing the brand name

What is the indication?
100
This is what the audit document is ensuring

What is that everything in the engine is in the approved submission? 

100

QA

What is Quality Assurance?

100

The number of rounds of QA before launch

What is four?

100

The next step taken only if all QA comes back clean

What is to go live?

200

The location we're allowed to show our branded ads

What is the USA (United States of America)?

200

The two types of errors you can get in the audit document

What are 'DNU/BAD' and 'not present in engine'?

200

FDA

What is the Food and Drug Administration?

200

The step of the QA that includes checking Google Analytics

What is the Post-Live QA?

200

The people responsible for ensuring compliance

Who is everybody?

300

These words are only allowed in ad copy for the first six months after FDA approval

What are 'new' and 'now approved'?

300

The pieces being checked in the audit

What is everything visible?

(ads, keywords, sitelinks, callouts, snippets, other extensions)

300

SF

What is Screaming Frog?

300

This job title completes the QA3 section of the checklist

What is supervisor+?
300

The person to report a compliance error to

Who is your manager?
400

This is how the FDA describes the relationship between information relating to side effects/contraindications and information relating to the effectiveness of a drug

What is fair balance?

400

Your next step after finding an error in the audit document during QA1

What is to remove/change the entity causing the error and to re-audit that section?

400

DNU

What is Do Not Use?

400

The level that ad extensions (especially sitelinks) should be added to

What are the campaign or ad group levels?

400

The amount that Novartis could be fined for a compliance error

What is six to seven figures?

500

This is what all branded ads are technically regarded as

What are reminder ads?

500

The two types of formulas used in the audit document to check whether what is in the engine is in the submission and vice versa

What are =VLOOKUP and =MATCH(TRUE,EXACT( ?

500

OPDP

What is the Office of Prescription Drug Promotion?

500

The two rules added to SA360 during the QA process

What are disapproved ads and disapproved keywords?

500

The way the FDA compliance tracker gets the keywords and ads for analysis

What is a web query?