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Learning Objectives. Explain the new drug development and review process in the United States. State how to obtain current drug information from the FDA. Food and Drug Administration. CBER. CDRH. NCTR. Center for Drug Evaluation and Research. ORA. CFSAN. CVM. CDER.

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Learning objectives

Learning Objectives

  • Explain the new drug development and review process in the United States.

  • State how to obtain current drug information from the FDA.


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Food and Drug Administration

CBER

CDRH

NCTR

Center for Drug Evaluation

and Research

ORA

CFSAN

CVM

CDER


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OFFICE OF REGULATORY AFFAIRS

OVER 160 OFFICES NATIONWIDE

NORTHEAST

AL

PACIFIC

CENTRAL

NH

ME

VT

ND

MN

WA

MA

NY

WI

SD

MT

RI

MI

CT

OR

NJ

PA

ID

OH

MD

IN

DE

IL

WV

VA

KY

NV

CA

WY

IA

NE

TN

NC

AZ

SC

UT

GA

AL

CO

KS

MS

PR

MO

HI

LA

OK

AR

NM

REGIONAL OFFICES - 5

DISTRICT OFFICES - 20

RESIDENT INSPECTION POSTS –100+

OCI FIELD OFFICES - 6

OCI RESIDENT OFFICES - 4

OCI DOMICILES - 4

FL

TX

SOUTHEAST

SOUTHWEST


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Office of the Center Director

Office of New Drugs

Office of Pharmaceutical Science

Office of Management

Office of New Drug Chemistry

Office of Medical Policy

Office of Drug Evaluation I

Office of Information

Technology

Office of Generic Drugs

Office of Drug Evaluation II

Office Training and

Communications

Office of Drug Evaluation III

Office of Clinical Pharmacology

and Biopharmaceutics

Office of Drug Evaluation IV

Office of Compliance

Office of Testing and

Research

Office of Drug Evaluation V

Office of Regulatory Policy

Office of Biotechnology

Products

Office of Drugs Evaluation VI

Office of Executive Programs

Office of Counter Terrorism

and Pediatric Drug Development

Office of Pharmacoepidemiology

and Statistical Science

Office of Information

Management


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A drug is defined as:

(A)articles recognized in the official USP, HPUS or NF or any supplement to any of them,

(B)articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,

(C)articles (other than food) intended to affect the structure or any function of the body of man or other function of the body of man or other animals…..


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What is a Biologic?

Any virus, therapeutic serum, toxic, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or its derivatives, applicable to the prevention treatment or cure of diseases or injuries of man.


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Industry

Guidance

http://www.access.gpo.gov/nara/cfr/


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SYNTHESIS

AND PURIFICATION

DISCOVERY/SCREENING

PRE-CLINICAL

RESEARCH

INDUSTRY TIME

FDA TIME

FDA & INDUSTRY TIME

SPONSOR/FDA MEETINGS ENCOURAGED


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PRE-CLINICAL

RESEARCH

CLINICAL STUDIES

SYNTHESIS

AND PURIFICATION

DISCOVERY/SCREENING

ANIMAL

TESTING

SHORT-TERM

LONG-TERM

INDUSTRY TIME

IND

NDA

FDA TIME

FDA & INDUSTRY TIME

SPONSOR/FDA MEETINGS ENCOURAGED


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PRE-CLINICAL

RESEARCH

CLINICAL STUDIES

FDA REVIEW

PHASE 1

SYNTHESIS

AND PURIFICATION

PHASE 2

PHASE 3

DISCOVERY/SCREENING

ANIMAL

TESTING

SHORT-TERM

LONG-TERM

INDUSTRY TIME

IND

NDA/ BLA

FDA ACTION

FDA TIME

FDA & INDUSTRY TIME

SPONSOR/FDA MEETINGS ENCOURAGED


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PHASE 1

PHASE 2

PHASE 3


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PRE-CLINICAL

RESEARCH

CLINICAL STUDIES

FDA REVIEW

PHASE 1

SYNTHESIS

AND PURIFICATION

PHASE 2

PHASE 3

DISCOVERY/SCREENING

ANIMAL

TESTING

SHORT-TERM

LONG-TERM

INDUSTRY TIME

IND

NDA/ BLA

FDA ACTION

FDA TIME

FDA & INDUSTRY TIME

SPONSOR/FDA MEETINGS ENCOURAGED


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PRE-CLINICAL

RESEARCH

POST

MARKETING

CLINICAL STUDIES

FDA REVIEW

ADVERSE

REACTION

SURVEILLANCE

PRODUCT DEFECT

REPORTING

PHASE 1

SYNTHESIS

AND PURIFICATION

PHASE 2

PHASE 3

PHASE 4

DISCOVERY/SCREENING

SURVEYS/

SAMPLING

TESTING

ANIMAL

TESTING

ACCELERATED APPROVAL

TREATMENT USE

SHORT-TERM

PARALLEL TRACK

POST APPROVAL

INSPECTIONS

LONG-TERM

INDUSTRY TIME

NDA/BLA

IND

FDA ACTION

FDA TIME

FDA & INDUSTRY TIME

ACCELERATED REVIEW:

SUBPART E

ACCELERATED REVIEW

EXPANDED ACCESS:

E

PARALLEL TRACK

SPONSOR/FDA MEETINGS ENCOURAGED

TREATMENT USE


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New Drug Application (NDA) or Biologic License Application

(BLA) contains the following:

  • Pre-clinical studies

  • Human clinical studies

  • Manufacturing details

  • Labeling

  • Additional information


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A Better Way

The equivalent of 50,000 paper pages of data..


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DRUG PRODUCT DIVISIONS

ODE I

ODE II

ODE III

ODE IV

ODE V

ODEVI

Anti-Inflammatory, Analgesic and Ophthalmologic

Anesthetic, Critical Care, and Addiction

Neuro-pharmacological

Gastrointestinal and Coagulation

Therapeutic

Biological

Oncology

Anti-Viral

Therapeutic

Biological

Internal

Medicine

Medical Imaging and Radiopharmaceuticals

Anti-Infective

Oncology

Pulmonary

Dermatologic and Dental

Metabolic and

Endocrine

Special Pathogen

and Immunologic

Reproductive

and Urologic

Over-the-

Counter

Review

Management &

Policy

Cardio-Renal


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Review Team

Project Manager

Medical Officer

Chemist

Microbiologist

Statistician

Pharmacologist

Establishment/Facility Reviewer

Support Personnel


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ADVISORY COMMITTEE

  • http://www.fda.gov/oc/advisory/default

  • Panel of OUTSIDE experts

  • Provide advice and opinions

  • to the FDA drug review team

  • FDA advisory committee

    • information, 1-800-741-8138 or 301-443-0572


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Prescription DrugUser Fee Act (PDUFA)

http://www.fda.gov/oc/pdufa/default.htm

  • Permits CDER/CBER to charge pharmaceutical manufacturers a fee to review drug applications

  • These fees provide appropriate resources to accelerate the review of applications

  • Not the only source of funds for CDER/CBER

  • Funds go directly to CDER/CBER, not individuals


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PRE-CLINICAL

RESEARCH

POST

MARKETING

CLINICAL STUDIES

FDA REVIEW

ADVERSE

REACTION

SURVEILLANCE

PRODUCT

DEFECT

REPORTING

PHASE 1

SYNTHESIS

AND PURIFICATION

PHASE 2

DISCOVERY/SCREENING

PHASE 3

PHASE 4

SURVEYS/

SAMPLING

TESTING

ANIMAL

TESTING

ACCELERATED APPROVAL

TREATMENT USE

SHORT-TERM

PARALLEL TRACK

POST APPROVAL

INSPECTIONS

LONG-TERM

INDUSTRY TIME

NDA

BLA

IND

ACTION

FDA TIME

FDA & INDUSTRY TIME

SPONSOR/FDA MEETINGS ENCOURAGED


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Post-market Surveillance


Office of drug safety

Office of Drug Safety

  • Division of Drug Risk Evaluation

  • Division of Medication Errors and Technical Support,

  • Division of Surveillance, Research, and Communication Support


Medwatch website

MedWatch Website

  • Safety Information Retrieval

  • Adverse Event Reporting for Drugs,Devices, Biologics and Dietary Supplements

www.fda.gov/medwatch


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Adverse Event Reporting System (AERS)

  • Database

  • Internationally compatible

Office of Drug Safety (ODS) uses AERS to:

  • triage

  • review

  • assess risk


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Potential Regulatory Action for Postmarketing Safety Issues

  • Labeling Change

  • Scientific publication

  • "Dear Doctor" letter (for specific warnings)

  • Restricted use

  • Restricted distribution

  • Patient Medication guide

  • Product withdrawal


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Benefits

Risks

Risks

Benefits

FDA

evaluates

benefits/risks

for the population

Provider

evaluates

benefits/risks

for a patient

Patient

evaluates

benefits/risks

in terms of

personal values


Ddmac division of drug marketing advertising and communications

DDMAC (Division of Drug Marketing Advertising and Communications)

  • Promotional Materials ReviewGuidances and policy development

  • Research

  • Surveillance and enforcement


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CDER’s Office of Compliance

  • Sets labeling, manufacturing, and testing standards

  • Monitors the quality of marketed drugs

  • Evaluates, classifies, and recommends human drug recalls


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Bioequivalence Review

Plant Inspection

Chemistry/Micro Review

Labeling Review

Generic Drug Review Process

Determine if application is acceptable

FDA reviews and decides if product is approved or not approvable

Application submitted to Office of Generic Drugs


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Definition of Bioequivalence

A generic drug is considered to be bioequivalent if:

  • The rate and extent of absorption do not show a significant difference from listed drug, or

  • The extent of absorption does not show a significant difference and any difference in rate is intentional or not medically significant


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APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS “Orange Book”

http://cdsmlweb1/ob/index.htm


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Orphan Drug Products

www.fda.gov/orphan

  • Rare diseases or conditions affecting fewer

  • than 200,000 people in the U.S.

  • 7 years exclusively after approval

  • Special financial incentives

  • Grants

  • Protocol Assistance


Three regions six parties

Three Regions, Six Parties

  • Europe

  • EUEFPIA

  • Japan

  • MHLWJPMA

  • United States of America

  • FDAPhRMA

    • Observers: WHO, Canada, EFTA


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New OTC drug

The sponsor/manufacturer submits a new drug application

(NDA) as an OTC drug.

Prescription to OTC Switch

The drug company submits a supplement to the new drug

application NDA to “switch” to OTC.

OTC Drug Review Process

FDA reviews active ingredients and finds they are safe

and effective. http://www.fda.gov/cder/Offices/OTC/industry.htm.


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Panel reviews all known data or any submitted by company

Advisory Panel Review

Agency input

ingredients

amounts

combinations

labeling claims

cat. I

cat. II

cat. III

ANPR FR

(Panel Report)

OTC DRUGREVIEW

Change in category could occur

-Public Comment-

Agency addresses comments

Agency review


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PR

(Tentative Final Monograph)

-Public Comment-

Agency review/

address comments

OTC DRUG REVIEW

cat. I monograph

cat. II nonmonograph

FR

(Final Monograph)

Codified in

CFR [April]


The new otc label

The New OTC Label


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  • Customize and Expand Enforcement Efforts

  • Partner with Federal, State and other Organizations

  • Engage in Public Outreach

  • http://www.fda.gov/oc/buyonline/default.htm

  • Cooperate Internationally

  • E-mail [email protected]


Counterterrorism

Counterterrorism

  • Help prevent or alleviate shortages of medically necessary drug products

  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002

  • Counterterrorism Drug Development

    • Radiation emergencies

    • Anthrax

    • Chemical agents


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Working with Partners to Meet

the Challenge


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www.fda.gov/cder


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www.fda.gov/cder

/http://www.fda.gov/cder/handbook/


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  • CDER’s Internet Home Page http://www.fda.gov/cder

  • Drug Information

  • 888-INFO-FDA or 301- 827-4573

  • [email protected]


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