Structure of FDA, Functions, Scope of FDA, New Drug Approval Process, NDA, ANDA, BLA, IND, etc. Adverse Drug Reporting Systems, OTC reviews, etc.

1. By: Group No. 1
Akshay Joshi (1)
Anjana Viswanathan (3)
Mukta Asudani (4)
Nagesh Bhaykate (6)
Pooja Borole (7)
Gaurav Andhansare (2)

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US FDA: Federal Agency of the US Dept. of Health & Human Services
Main responsibility is protecting the public health by assuring the safety, effectiveness,
quality, and security of human and veterinary drugs, vaccines and other biological
products, and medical devices
Introduction

3. Organization of FDA
US FDA
Office of
Commissioner
Office of Foods &
Veterinary
Medicine
Office of Medical
Products &
Tobacco
Office of Global
Regulatory
Operations and
Policy
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4. Organization of FDA
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Office of Medical
Products & Tobacco
Centre for Drug
Evaluation and
Research
Office of Generic
Drugs
Office of New Drugs
SSMRDs
Office of
Prescription Drugs
Promotion
(formerly DDMAC)
Centre for Biologics
Evaluation and
Research
Centre for Devices
and Radiological
Health
Centre for Tobacco
Products
Office of Special
Medical Programs

5. Introduction
What does FDA regulate?
1. Animal & Veterinary
2. Cosmetics
3. Drugs
4. Food
5. Medical Devices
6. Radiation emitting products
7. Tobacco Products
8. Vaccines, Blood products and biologics
How does it regulate?
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6. Types of Application: IND
PURPOSE:
• Permission to ship an experimental drug across states before a marketing
application for the drug has been approved.
• To propose a study of an unapproved drug, or a study of an approved product
for a new indication or in a new patient population.
FDA's Role -- when the drug's sponsor has screened the new molecule for
pharmacological activity and acute toxicity potential in animals and wants to test
its diagnostic or therapeutic potential in humans.
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7. Types of Application: IND
Types:
• Investigator IND
• Emergency Use IND
• Treatment IND
Classification of IND
• Commercial
• Non Commercial (Research)
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9. Types of Application: IND
Contents of IND Application:
• Animal Pharmacology and Toxicology Studies
• Manufacturing Information
• Clinical Protocols and Investigator Information
Once the IND is submitted, the sponsor must wait 30 days before initiating any clinical
trials
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12. Types of Application: NDA
• Marketing Approval of a Drug in the US
• Data gathered during the animal studies and human clinical trials of an Investigational new product
become part of the NDA
• Goals of NDA
• Types of NDA
1. 505 (b)(1)
2. 505 (b)(2)
3. 505 (j)
• Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will
assess whether the NDA is "sufficiently complete to permit a substantive review”
• Form FDA 356h – Application to market a New Drug.
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505(b)(1) 505(b)(2) 505(j)
Type of product
Drug molecule not approved
before by the FDA
Approved drug by the FDA but which is
either a NCE/NME or with new changes
(not just duplication)
Duplication of previously approved drug with
identical specifications (API, strength, dosage
forms, etc.)
Type of Information
required
Complete reports of Investigations
of safety and effectiveness
Complete reports of Investigations of
safety and effectiveness but some of the
information required for approval comes
from studies not conducted by the
applicant
To show that the proposed product is identical
in active ingredients, dosage form, strength,
route of administration, quality to a previously
approved product.
Only Bioequivalence need to be established
Data ownership Applicant is the Owner of the Data
Applicant does not have a right of
reference or right of use of data (or part of
it) submitted
Data from Agency of NDA is relied upon
Purpose of
Application
Approval of a new drug (for clinical
use) whose active ingredient has
not previously been approved
Approval of a new drug that relies, at least
in part, on data not developed by the
applicant
Approval of a “generic” version of a drug that
has already been approved
User Fees Yes Yes No
Patent Period /
Market Exclusivity
20 years from date of filing
Effectively 8-10 years*
3 years (Formulation/Indication)
5 years (NCE)
7 years (Orphan)
6 months if FTF
Average FDA Review
Period
Approx. 10-12 months Approx. 12 months Approx. 27 months

16. Types of Application: OTC
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Drugs that are safe and effective for use by the general public without a
prescription.
Play an increasingly vital role in health care system.
Are considered safe if warnings and directions are followed.
Labelling is regulated by FDA
Advertising is regulated by Federal Trade Commission(FTC)

17. Types of Application: OTC
• OTC Drug Categories:
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Antacids
Antiemetic
Antihistamine
Cough
Medicine
Decongestant
Laxatives
 Vitamins
Pain Killers
Herbal
Products

18. Types of Application: OTC
Drug Monograph Process
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 FDA's review of OTC drugs is primarily handled by CDER's Office of Drug Evaluation IV.
 Advisory panel review
• Category I: generally recognized as safe and effective for the claimed therapeutic indication
• Category II: not generally recognized as safe and effective or unacceptable indications
• Category III: insufficient data available to permit final classification
 Creation of tentative Monograph (agency’s review)
 Publication of Final monograph
 FDA approval

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Types of Application: OTC

20. Types of Application: OTC
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• Two Regulatory pathways exist for the legal marketing of such product
• NDA process
• OTC Monographs
NDA Process OTC Monographs
• Pre-marketing approval
• Confidential filling
• Drug product are specify
• May require a user fee
• Potential for marketing exclusivity
• Mandated FDA review timelines
• May require clinical studies
• No Pre-marketing approval
• Public process
• Active ingredient –specific
• No user fees
• No marketing exclusivity
• No mandated time lines
• May require clinical studies

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IND NDA BLA ANDA OTC
Covered under FDC Act FDC Act PHS Act
FDC Act,
Hatch-Waxman
Act, BPCIA
FDC Act
Reviewed by CDER/CBER CDER CBER CDER, OGD
CDER (ODE IV)
and FTC
Listed in - Orange Book Purple Book Orange Book
OTC Monograph
and Federal
Register
Type of application Research Marketing Marketing Marketing Marketing
Data
available/required
Preclinical,
CMC,
Proposed CT
protocol
Clinical, CMC,
proposed labelling
Clinical, CMC,
proposed labelling
BA/BE
Additional safety
studies, labelling
info
Types
Investigator
initiated
Emergency
Treatment
505(b)(1)
505(b)(2)
351(a)
Generic – 505(j)
Biosimilar – 351(k)
-
Comparison between IND, NDA, ANDA, BLA and OTC

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FAERS: FDA Adverse Event Reporting System (in accordance with ICH E2B)
• Who can report?
• How can one report?
• Is it made public?
• Any Limitations?
Safety

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Drug Recalls
 By: Pharmaceutical firm, FDA request, other statutory body ordering FDA
 Classification:
 Class I: Reasonable probability of serious adverse health consequences or death
 Class II: May cause temporary or medically reversible adverse health consequence or
remote probability of serious adverse health consequences
 Class III: Not likely to cause adverse health consequences
 Market withdrawal: Minor violation which may not qualify for legal action by FDA
 Medical device safety alert
 Information made public through website
Safety