# Presentation: 253314

## The TOP TEN THINGSIndustry can do to improve the review process

- Tim Ames
-  Chief, Review Support Branch
- June 26, 2003

## The TOP TEN THINGS

- Organization of the ANDA
- Follow the guidance--reviewers say that having a well-formatted, well-tabbed ANDA and amendments can literally cut the review time in half.
- Avoid Redundancy
- Do not submit redundant data.
- Reference data that is already included in the application and provide an abstract-like summary at the beginning of a data submission.
- The reviewers must review any data submitted even if it is redundant.

## The TOP TEN THINGS	

- Include a summary table for the Methods Validation to include:
- Analytical method number and purpose of method.
- Basis of the method as GC, HPLC, etc.
- Limit of detection, limit of quantitation and RSD for each method with justification if needed.

**Notes:**
-Weekly meetings are held to review applications that are potentially approvable.  This means that the chemistry review is okay.
-This places the drug on an application matrix.  When this happens the drug goes to the top of the priority list for other areas such as bioequivalence, microbiology, and labeling.
-The chemistry review drives the rest of the reviews
-

## The TOP TEN THINGS	

- For Outside Firms:
- When submitting the manufacturing and testing facilities, obtain and submit the CFN number and the complete street address of the facility (not just the city and state).  Also, if there was a recent change in the facility's name, include the facility's former name.
- Specify content of amendments clearly in cover letter as Bioequivalence, Minor, Major, Labeling, Microbiology or a complete combination.

## The TOP TEN THINGS	

- Include FDA 356h forms and correct ANDA **#** with all your amendments. Fax in both the cover letter and 356h form when responding to a Telephone Amendment.
- Always call the PM, TL or Reviewer before faxing in requested or additional information.  Fax a copy of the Telephone Amendment _**to the PM**_ so that they are aware it is in-house and can start the review process.

**Notes:**
Pediatric exclusivity is granted to the drug substance itself.
-Pediatric exclusivity therefore covers all formulations and dosage forms.
-Pediatric exclusivity is limited to 6 months 
-A company may win a second pediatric exclusivity by filing a labeling supplement.  

## The TOP TEN THINGS	

- Regarding Teleconference requests:
- They are for providing clarification, not pre-review of responses.
- Fax in an agenda of deficiencies you want clarified and why.
- Include a suggested date and time of the T-con, at least several days after submitting the agenda request.

**Notes:**
Pediatric exclusivity is granted to the drug substance itself.
-Pediatric exclusivity therefore covers all formulations and dosage forms.
-Pediatric exclusivity is limited to 6 months 
-A company may win a second pediatric exclusivity by filing a labeling supplement.  

## The TOP TEN THINGS	

- When submitting a Minor amendment to Request Full Approval after receiving a Tentative Approval:
- Call the PM to check upon its receipt and assignment to the Chemistry queue (after 5-7 working days).
- Include notification of all types of information submitted, e.g., Labeling, Bioequivalence, Chemistry etc.
- Certify if no changes have been made to the CMC portion of the ANDA since the TA.

**Notes:**
Pediatric exclusivity is granted to the drug substance itself.
-Pediatric exclusivity therefore covers all formulations and dosage forms.
-Pediatric exclusivity is limited to 6 months 
-A company may win a second pediatric exclusivity by filing a labeling supplement.  

## The TOP TEN THINGS	

- Calling for Review Status:
- Understand that review times for Minor Amendments has increased.  Once a review has been drafted by the reviewer it undergoes 2° & 3° reviews before being finalized, which may take 10-15 working days.
- Leave specific questions on voice mail, including the ANDA #s and what’s the issue, e.g., status request, requesting clarification/T-Con, checking on CBE status, or receipt of a submission, etc.
- A response to a voice message may take 24-48 hours.
-  Multiple calls on the same subject are detrimental to the review process.  Badgering is unacceptable.

**Notes:**
Pediatric exclusivity is granted to the drug substance itself.
-Pediatric exclusivity therefore covers all formulations and dosage forms.
-Pediatric exclusivity is limited to 6 months 
-A company may win a second pediatric exclusivity by filing a labeling supplement.