Download - OTC Sunscreen - Content and Withdr
CONTENT AND FORMAT OF DATA SUBMISSIONS
586A REQUEST WITHDRAWAL
ADVISORY COMMITTEE PROCESS
Over-the-Counter (OTC) Sunscreens
Guidance Summary
Presented by: Sandeepkumar Balabbigari
March 11th 2016
Regulatory BackgroundThe Sunscreen Innovation Act (SIA) was
designed to amend the Food, Drug, and
Cosmetic Act to spur the review or approval
of OTC sunscreens
Sunscreens are regulated by either the:
• New drug approval process: products may not be
marketed without FDA’s prior review and approval
for each product
• OTC drug monograph process: active ingredients
that are determined to be GRASE in a final
sunscreen order may be marketed in a sunscreen
product without obtaining NDA or ANDA approval
Content and Format of
Data Submission
Purpose
Addresses the format and content of
data needed to support GRASE
determination of a single or a
combination of OTC sunscreen active
ingredient(s) in 586A requests
Industry RequirementsAll data and information relevant for GRASE
determination for each active ingredient in the
586A request should be provided in a single
submission using the format detailed in the
Common Technical Document (CTD)
Previously submitted data can be used for
GRASE determination but a copy of the
information must be identified and provided
in the current submission
Data should be made publicly available
Electronic submission are encouraged
Data Submission Modules
Module 1: Administrative Information
Module 2: Overview and Summary
of Modules 3 to 5
Module 3: Relevant Quality Information
Module 4: Preclinical Data
(Pharmacology/Toxicology)
Module 5: Clinical Safety and Efficacy
Module 1, 2, and 3Module 1: Administrative Information
• Labeling information
• Statements about confidential information
• Cover letter
• Financial disclosure
Module 2: Overview and Summary
of Modules 3 to 5
• Summaries of evidence that supports and does not
support that the active ingredient is GRASE
Module 3: Quality Data
• Active ingredient(s)’ current compendia status
• Chemical and manufacturing characteristics
Module 4 & 5Module 4: Preclinical Data
• Data and reports from nonclinical studies discussed
in the Safety and Efficacy Draft Guidance
• Any other types of nonclinical information
Module 5: Clinical Safety and Efficacy
• Comprehensive and integrated summaries of
effectiveness and clinical safety
• Full reports of all clinical effectiveness and safety
studies, clinical pharmacology and human
toxicokinetic data, and other clinical data from
other published materials
586A Request Withdrawal
Purpose
Addresses the process sponsors must
follow to withdraw a 586A request and
pending request
586A Request
Withdrawal Process
Sponsors seeking to withdraw a 586A request should
submit a written or electronic request to the docket
with a copy to the Division of Nonprescription Drug
Products in the Office of Drug Evaluation IV
Sponsors may request a withdrawal of their 586A
request during any point of the SIA process (initial
eligibility determination, data submission, filing
determination, GRASE determination)
FDA may withdraw a sponsor’s 586A request if the
sponsor fails to respond within 90 days of request for
information or data regarding the submission
Industry Requirements
Withdrawal request should include:
• Submitter
• Submission date
• Active ingredient/subject of the submission
• Docket number
Advisory Committee Process
Purpose
Provides an overview of the advisory
committee process and the convening of
the Nonprescription Drugs Advisory
Committee (NDAC)
Nonprescription Drugs Advisory
Committee (NDAC) OverviewEstablished under the Federal Advisory
Committee Act
Reviews and evaluates data concerning the
safety and effectiveness of OTC drug
products, advises FDA on monograph
requirements for GRASE determination
Consists of 10 voting members from various
areas of healthcare
May take 4 to 6 months to prepare for an
NDAC meeting
NDAC Requests
Sponsors can request FDA to convene
the NDAC to consider the issues related
to the sponsors’ 586A request
FDA may also convene the NDAC for
any 586A request regardless of whether
the sponsor has made a NDAC request
THANK YOU!
QUESTIONS?