overview of us fda: drugs

By: Group No. 1Akshay Joshi (1)

Anjana Viswanathan (3)Mukta Asudani (4)

Nagesh Bhaykate (6)Pooja Borole (7)

Gaurav Andhansare (2)

05/01/20232 Regulatory Affairs

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

05/01/2023Regulatory Affairs3

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


Organization of FDA

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


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?


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.



Types:• Investigator IND

• Emergency Use IND

• Treatment IND

Classification of IND• Commercial

• Non Commercial (Research)



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


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.


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 DataApplicant 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 filingEffectively 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


Types of Application: OTC

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)



• OTC Drug Categories:

Antacids Antiemetic

Antihistamine

Cough Medicine DecongestantLaxatives

Vitamins Pain Killers

Herbal Products



Drug Monograph Process

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



• 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


IND NDA BLA ANDA OTC

Covered under FDC Act FDC Act PHS ActFDC 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 BookOTC 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

EmergencyTreatment

505(b)(1)505(b)(2) 351(a) Generic – 505(j)

Biosimilar – 351(k) -

Comparison between IND, NDA, ANDA, BLA and OTC


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


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

overview of us fda: drugs

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