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U.S. Department of Health and Human Services

Drugs

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LRB QBR for Transdermal Systems

INTRODUCTION:                     

ANDA Number
Date of Submission
Applicant’s Name
Established Name of the Drug Product
Proprietary Name of the Drug Product (include date proposed)
Labeling Submissions
  
QbR Questions:
 
1.     What is the basis of submission of this ANDA?
2.     How does your product meet requirements of the USP Monograph?
3.     What are the currently approved patents and exclusivities for the reference listed drug? 
4.     What are the certifications and labeling impacts for each patent and exclusivity?
5.     Do any of your inactive ingredients require special labeling statements or have regulatory requirements?
6.     Is the listing of inactive ingredients in the DESCRIPTION section of the package insert consistent with the listing of inactive ingredients found in the statement of components and composition and SPL data elements?
7.     Who manufactures the drug product?
8.     Are the labeling conditions for manufacturer and/or distributor met?
9.     Who distributes the drug product?
10.   How does your product description compare with the product description of the RLD?
11.   How does your product description compare with the product description in the Finished Product Specifications?
12.   Describe the mechanism of action for release of the product from the transdermal system.
13.   Does the product contain any foil or metal?
14.   How is the product to be disposed of?  What information is provided to patient and provider regarding disposal?
15.   Does your system size or amount of active ingredients differ from the RLD?  If so, justify this difference. 
16.   What warnings and information are present in the labeling about the product?
17.   What is the Tmax reported in the RLD labeling?  Compare the release kinetics (including Tmax) of your product with those of the RLD. 
18.   Does a USP monograph set forth a specification for this product?
19.   What instructions are present for the patient about this product's use?
20.   What container/closure system(s) is proposed for the drug product? 
21.   What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
22.   How do your container/closure features compare with the container/closure features of the RLD?
23.   How have you satisfied specific container/closure requirements for your drug product and/or package configuration, if applicable?
24.   How do your package configurations compare with the package configurations of the RLD?
25.   Does the proposed package have any safety and/or regulatory concerns?
26.   How does your storage temperature statement compare with the storage temperature statement of the RLD?
27.   How do your stability studies and data support your storage temperature statement and expiration date?
28.   Are storage recommendations consistent with the USP monograph for this product?
29.   Is this product light sensitive?  If so, do the labeling recommendations and/or special packaging address light sensitivity? 
30.   How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
31.   Are the data elements consistent with information provided in your application?
32.   Are the FDA Toll Free number, MedWatch web address and manufacturer’s phone number present in the labeling?
33.   Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
34.   Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
35.   Is your proposed product subject to any petitions?
36.   Does your proposed labeling provide Clinical Pharmacology information which can be compared to information submitted with this application, for example, Tmax, AUC, affect of food? 
37.   Have you provided comparison of information from studies cited in your application to the information proposed in the labeling?
 
Additional Questions:
 
Over-The-Counter 
1.     Is your product an Over-the-Counter medication?
2.     If so, explain how it meets content and format regulations set forth in the regulations?
3.     Have you included a legend with your submission?
4.     How does your product meet tamper-resistant requirements set forth in 21 CFR 211.132?
  
Controlled Substance Labeling 
1.     Is your product a controlled substance?
2.     If yes, does labeling meet regulatory requirements for location and size of symbol?
3.     Does the proposed packaging meet requirements for tamper-evident sealing?
 
NDC Codes 
1.     Is your drug product registered?
2.     Does your product meet the conditions of 21 CFR 207.35(b)(3)(i), regarding the proper placement of the NDC code on labeling?
 
Lot Numbers 
1.     Does a lot number, control number, or batch number appear on the label as described in 21 CFR 201.18?
  
Bar Coding 
1.     How are the conditions of 21 CFR 201.25 met?
                                              
Formatting, wording preferences
1.     Do your labels and labeling meet formatting requirements set forth in the regulations, e.g., font size?
 
Instructions for Use 
1.     How do the instructions for use differ from those of the Reference Listed Drug (RLD)?
2.     If the instructions differ from the RLD, have similar instructions been approved for another of your approved drug products? 
 
Medication Guides 
1.     How does the Medication Guide for this product differ from that approved for the RLD?
2.     How will the Medication Guide be provided with the product and how many will accompany each package size?
3.     Are the conditions of 21 CFR 208.20 met with regard to proper Medication Guide formatting?
4.     Do the proposed container labels direct the health care provider to dispense the Medication Guide as required by 21 CFR 208.24(d)?
5.     Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the Medication Guide?
 
Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA 1088.
 
Patient Information Leaflet 
1.     How does the Patient Information Leaflet for this product differ from that approved for the RLD?
2.     How will the Patient Information Leaflet be provided with the product and how many will accompany each package size?
3.     Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the patient information?
 
Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA 1088.
  
Differentiation
1.     Are your product strengths sufficiently differentiated to reduce chance of medication errors?
2.     Where there is a possibility the products will be stored in close proximity, is there adequate differentiation between your proposed product and your approved products? 
3.     Is there sufficient contrast between the expression of strength and background color on container labels and carton labeling? 
  
Product-Specific Statements
1.     Are you proposing a product with Tall Man Lettering?
2.     Does your labeling meet the requirements set forth in the regulations?
3.     Do you have the proper warning statements set forth in the regulations?