Usfda swatee

A SEMINAR ON
UNITED STATES FOOD AND
DRUG ADMINISTRATION (USFDA)
Presented by:- Singh Swati Raghubansh
M.Pharm Sem-II
Department Of Pharmaceutics
ROFEL Shri G.M. Bilakhia College Of Pharmacy, Vapi.
1

CONTENTS
 History
 Defination
 What is the need?
 FDA Objectives
 Scope of FDA
 FDA Components
 Evaluation Process
 Who makes up FDA?
 FDA Mission
 FDA Inspection
 Laws enforced by FDA
 FDAActivities
 What Is New
 Challenges faced by
FDA
 USFDA in India
 References
2

HISTORY
 From the beginnings of civilization people have been concerned
about the quality and safety of foods and medicines.
 Regulation of food in the United States dates from early colonial
times.
 Federal controls over the drug supply began with inspection of
imported drugs in 1848.
3

DEFINATION
USFDA:- The U.S. Food and Drug Administration (FDA) is
an agency of the US Department of Health and Human Services
The FDA is responsible for regulating and supervising the safety
of;
 Foods
 Tobacco products
 Dietary supplements
 Prescription and non-prescription medications
 Vaccines
 Biopharmaceuticals
 Blood transfusions
Medical devices
 Electro magnetic radiation emitting devices
 Veterinary products & Cosmetics4

 The FDA has its headquarters at White Oak, Maryland. The
agency also has 223 field offices and 13 laboratories located
throughout the 50 states, the United States Virgin Islands and
Puerto Rico.
 In 2008, the FDA started opening offices in foreign countries,
including China , India , Costa Rica , Chile , Belgium and the
United Kingdom.
5

 In short, to Promote and protect the public health by helping
safe and effective products reach the market in a timely way.
 To Monitor products for continued safety after they are in
use.
 To Help the public get the accurate, science-based information
needed to improve health.
8

SCOPE
 To provide safe and effective Medicine, Biological and
Medicinal devices.
 To provide safe, effective and sanitary Food.
 To provide truthful and informative label.
 To provide safe and effective Animal Drugs.
 For facilitating safe consumer and Medical Radiation
products.
9

Sr.
No
Component Full Form Regulates
1. CBER Center For Biologicals
Evaluation And Research
Biological Products
2. CDRH Center For Devices And
Radiological Health
Safety and Effectiveness of New Medical
Devices Before they are Marketed
3. CDER Center For Drug Evaluation
And Research
Health of by Assuring Prescription and
OTC Drugs are Safe and Effective
4. CSFAN Center For Food Safety And
Applied Nutrition
Food Supply is Safe, Sanitary,
Wholesome, and Honestly Labeled, and
Cosmetic Products are Safe and Properly
Labeled.
5. CVM Center For Veterinary
Medicine
Assure that Animal Food Products are
Safe.
6. NCTR National Center For
Toxicological Research
Human Toxicity
7. OC Office Of The Commissioner
8. ORA Office Of Regulatory Affairs Products Comply with Appropriate Public
Health Laws and Regulations.11

CBER
 CBER regulates biological products to advancing the public
health through innovative regulations that ensures;
the safety
effectiveness and
timely delivery to patients of biological products.
 Current authority for this responsibility resides in Section 351 of
the Public Health Service Act and in specific sections of the Food
Drug and Cosmetic Act.
 The mission of CBER is to protect and enhance the public health
through the regulation of biological and related products.
12

 PRODUCTS REGULATED BY CBER
 Blood.
 Devices.
 Vaccines.
 Cellular therapy.
 Tissue.
 Xenotransplantation products.
 Human Tissue & Cellular products.
 Allergenics.
13

 It is Center for Devices and Radiological Health.
To makes sure that new medical devices are safe and effective before
they are marketed.
 The center also monitors devices throughout the product life cycle,
including a nationwide postmarket surveillance system.
 And it assures that radiation-emitting products, such as microwave
ovens, TV sets, cell phones, and laser products meet radiation safety
standards.
CDRH
14

CDER
 The FDA's Center for Drug Evaluation and Research (CDER)
promotes and protects the health;
 by assuring that all prescription and
 over-the-counter drugs are safe and effective.
 CDER evaluates all new drugs before they are sold, and serves as
a consumer guide for the more than 10,000 drugs on the market to
be sure they continue to meet the highest standards.
15

 Drug information provided by CDER
The following types of drug information is provided by CDER.
 New Prescription Drug Approval
 Prescription Drug Information
 Drug Information Pathfinder
 Major Drug Information Pages
 Consumer Drug Information
 Over-the-Counter Drug Information
 Drug Safety & Side Effects
 Drug Preparedness and Bioterrorism Response
 Clinical Trials Information
 Public Health Alerts & Warning Letters
 Reports and Publications
 Special Projects & Programs
16

CFSAN
 The Center for Food Safety and Applied Nutrition, known as
CFSAN, is one of six product-oriented centers, in addition to a
nationwide field force, that carry out the mission of the Food and
Drug Administration (FDA).
 The mission of CFSAN is, promoting and protecting the public's
health by ensuring that the nation's food supply is;
 safe,
 sanitary,
 wholesome, and
 honestly labeled, and
 that cosmetic products are safe and properly labeled.
17

 Responsibilities of CFSAN are as follows;
 The safety of substances added to food, like food and color
additives.
 The safety of foods and ingredients developed through
biotechnology.
 Seafood hazard analysis and critical control point (HACCP)
regulations.
 Health risks associated with food borne chemical, and biological
contaminants.
 Regulations and activities dealing with the proper labeling of
foods and cosmetics.
 Policy governing the safety of dietary supplements, infant
formulas, and medical foods.
 Food industry postmarketing surveillance and compliance.
 Consumer education and industry outreach.
 Cooperative programs with state and local governments.
18

 Some of CFSAN's current areas of food safety concern are:
 Biological pathogens (e.g., bacteria, viruses, parasites)
 Naturally occurring toxins (e.g., mycotoxins, ciguatera toxin,
paralytic shellfish poison)
 Dietary supplements (e.g., ephedra)
 Pesticide residues
 Toxic metals (e.g., lead, mercury)
 Decomposition and filth (e.g., insect fragments)
 Food allergens (e.g., eggs, peanuts, wheat, milk)
 Nutrient concerns (e.g., vitamin D overdose, ediatric iron
toxicity)
 Dietary components (e.g., fat, cholesterol)
 Radionuclides
 Product tampering
19

CVM
 The FDA's Center for Veterinary Medicine (CVM) evaluates the
safety and effectiveness of drugs used to treat animals.
 Nearly 300 drugs currently on the market have been approved by
the FDA for dogs, cats and horses.
 CVM has two top priorities;
1. Prevent the establishment of bovine spongiform encephalopathy
(BSE), "mad cow disease." &
2. Counter the risk of antibiotic resistance in humans from animal
food.
 CVM regulates the manufacture and distribution of food additives
and drugs that will be given to animals.
 CVM is responsible for regulating drugs, devices, and food
additives given to animals like poultry, cattle, swine, and minor
animal species (other than cattle, swine, chickens, turkeys horses,
dogs, and cats).
20

NCTR
 All of the research performed at the National Center for
Toxicological Research is targeted to fulfill three strategic
research goals in support of FDA's public health mission.
1. Developing new strategies and methods to test/predict toxicity
and assess/detect risk for FDA-regulated products, both new
and those already on the market (Risk Assessment for
Regulated Products)
2. Developing computer-based systems (knowledge bases) that
predict human risk to enhance the efficiency and effectiveness
of premarket product reviews (Knowledge Bases that Predict
Human Toxicity)
3. Conducting research to understand mechanisms of toxicity,
assess new product technology, and provide methods for use
in FDA standards development and product risk surveillance
(Methods use for FDA Standard Development and Product
Risk Surveillance)21

This research is aimed at understanding critical biological
events in the expression of toxicity and at developing
methods to improve assessment of human exposure,
susceptibility and risk.
NCTR Includes
Centre of
Excellence
Research
Division
22

NCTR
Centre of Excellence
Toxico
informatics
Photo
toxicology
Functional
Genomics
Structural
Genomics
Hepato
toxicology
Metabolomics Proteomics
23

OC
 The Office of the Commissioner is made up of several
components,
 Ethics Program
 Good Clinical Practice Program
 History Office
 Office of Combination Products
 Office of Crisis Management
 Office of Equal Employment Opportunity
 Office of Financial Management
 Office of International Programs
 Office of the Ombudsman
 Office of Orphan Products Development
 Office of Pediatric Therapeutics
 Office of Planning & Policy
 Office of Public Affairs
 Office of Special Health Issues
 Office of Women's Health25

ORA
 Office of Regulatory Affairs ensure that FDA regulated products
comply with appropriate public health laws and regulations.
 ORA specialists compromise of;
 Consumer safety Officers (CSO) and Inspectors conduct domestic
and foreign inspections a year to ensure that regulated products
destined for the US market meet the agency’s standards. Plants are
inspected both before the FDA approves a product to make sure that
the firm has the capacity for high-quality production and
periodically afterwards, to ascertain that it follows appropriate
manufacturing processes. CSO also monitor clinical trials.
 Scientists in ORA’s laboratories analyze product samples to
determine their adherence to the FDA’s standards. Products
(domestic as well as foreign) that do not measure up to FDA
standards are not allowed on the U.S. market.
 Public affairs specialists reach out to consumer groups, health care
professionals, and state health authorities to explain FDA policies.26

 Compliance Strategies of ORA includes,
 Providing information to industry
 Highlighting areas of significant violations and impact on public
health
 Prioritizing and targeting high-risk areas
 Cooperating with state and local public health authorities and
regulators
 Focusing on covering products imported into the US through
border coverage and foreign inspections.
27

COSMETICS
 FDA is only able to regulate cosmetics after products are
released to the market place.
 Neither cosmetic products nor cosmetic ingredients (except color
additives) are reviewed or approved by FDA before they are sold
to the public.
 It Includes,
 Animal Testing for Cosmetic Products
 Inspection of Cosmetics
 Shelf life
 Federal Food, Drug, and Cosmetic Act (FD&C Act) and
 Fair Packaging and Labeling Act (FPLA)
28

I. Animal Testing for Cosmetic Products
 FDA does not mandate to do animal testing
 FDA develop validated alternatives to animal testing in assessing
cosmetic safety
II. Inspection of Cosmetics
 An investigator may look for the following,
 Use of prohibited ingredients
 Improper use of restricted ingredients noncompliance with
requirements related to color additives
 Microbial contamination
 Failure to adhere to requirements for tamper-resistant packaging
 Deficiencies in labeling and packaging
29

III. Shelf Life
 No regulations or requirements under current united states law
 Manufacturers have the responsibility to determine shelf life
for products
IV. Cosmetic Labeling
 The name of manufacturer, packer or distributor
 Place of business of the manufacturer, packer or distributor
 An accurate statement of the quantity of contents
 Any appropriate directions for safe use and
 Warning statements
30

EVALUATION PROCESSS
CDER evaluates safety and effectiveness of drug
In vitro-in vivo testing of new drug by the company
Check and submit investigation
Company submit IND for FDAs review
Company sends data to CDER in NDA
CDER review the data and proposed labeling
If risk-benefit ratio is established, the drug is approved for sale
After launching the drug , the FDA monitors its performance by using
MEDWATCH.
31

WHO MAKES UP FDA?
The FDA consists of employees drawn from a wealth of science
and public health professions.
 Biologists, physicians, chemists, biomedical engineers
toxicologists, pharmacologists, veterinarians, and specialists in the
public health education and communication.
 FDA employs approximately 11,516 people who work in
locations around the United States.
32

FDA MISSION
Mission
Statement
FDA
Strategic
Plan
FDA
Customer
Service
Standards
What
FDA
Regulates
What
FDA
Does
Not
Regulate
Laws
Enforced
By
FDA
33

MISSION STATEMENT
 The FDA is responsible for protecting the public health by
assuring the safety, efficacy, and security of ;
 Human and veterinary drugs,
 Biological products,
 Medical devices,
 Our nation’s food supply,
 Cosmetics, and
 Products that emit radiation.
 The FDA is also responsible for advancing the public health by
helping to speed innovations that make medicines and foods more
effective, safer, and affordable.
 And helping the public to get the accurate, science-based
information they need to use medicines and foods to improve their
health.
34

FDA CUSTOMER SERVICE STANDARDS
I. Customers
II. Health professionals
III. Regulated industry
IV. Other government agencies
36

Customers
 Fair, courteous and professional treatment
 Information that is accurate and current
 Timely responses to requests
 Reasonable access to appropriate staff
 Confidence that efforts are made to assure that regulated products
in the marketplace are in compliance with FDA laws and
regulations,
 Two-way communication
 Opportunities for collaboration and partnerships
 Participation in the agency's decision-making process
 Accurate and timely health information about regulated products
37

Health Professionals
 Timely information that will assist them in advancing and
protecting the public health
Regulated Industry
 Timely review of product applications,
 Professional treatment in resolving disputes,
 Fair application of laws and regulations in enforcement
activities,
 Fair and consistent inspections and product application reviews,
 Respect in the agency's performance of duties and
responsibilities.
38

WHAT FDA REGULATES
 Biologicals
 Product and manufacturing establishment licensing
 Safety of the nation's blood supply
 Research to establish product standards and develop
improved testing methods
 Cosmetics
 Safety
 Labeling
 Drugs
 Product approvals
 OTC and prescription drug labeling
 Drug manufacturing standards
 Foods Safety of all food products (except meat and poultry)
 Bottled water
 Medical devices
 Premarket approval of new devices39

 Manufacturing and performance standards
 Tracking reports of device malfunctioning and serious adverse
reactions
 Radiation-emitting electronic products
 Radiation safety performance standards for microwave ovens,
television receivers, diagnostic
 X-ray equipment, cabinet x-ray systems (such as baggage x-
rays at airports), laser products,
 Ultrasonic therapy equipment, mercury vapor lamps, and
sunlamps
 Accrediting and inspecting mammography facilities
 Veterinary products
40

WHAT FDA DOES NOT REGULATE
Advertising
Alcohol
Consumer Products
Drugs of Abuse
Health Insurance
Meat and Poultry
Pesticides
Restaurants and Grocery Stores
Water
41

WHAT DOES FDA INSPECT
 FDA inspects manufacturers or processors of FDA regulated
products to verify that they comply with relevant regulations.
Inspection include:
 Vaccine and drug manufacturers
 Blood banks
 Food processing facilities
 Dairy farms
Animal feed processors
FDA also inspects..
 Facilities that conduct studies in people (clinical trials).
 Laboratories that conduct studies in animals or microorganisms
when these studies are used to apply for FDA approval of a medical
product.
42

Foreign manufacturing and processing sites for FDA- regulated
products that are sold in the United States.
Imported products at the border.
 FDA conducts several types of inspections to help protect
consumers from unsafe products:
Pre-approval inspection after a company submits an application to
FDA to market a new product.
Routine inspection of a regulated facility.
“For-cause” inspection to investigate a specific problem that has
come to FDA’s attention.
43

LAWS ENFORCED BY FDA
 Federal Food, Drug and Cosmetic Act
 Food and Drug Administration Modernization Act (FDAMA)
 Infant Formula Act of 1980
 Orphan Drug Act
 Drug Price Competition and Patent Term Restoration Act of
1984
 Medical Device Amendments of 1992
 Prescription Drug User Fee Act (PDUFA) of 1992
 Animal Medicinal Drug Use Clarification Act (AMDUCA) of
1994
 Dietary Supplement Health and Education Act of 1994
 Food and Drug Administration Modernization Act (FDAMA)
of 1997
 Best Pharmaceuticals for Children Act
44

 Medical Device User Fee and Modernization Act (MDUFMA) of
2002
 Animal Drug User Fee Act of 2003 PDF
 Minor Use and Minor Species Animal Health Act of 2004
 Food Allergen Labeling and Consumer Protection Act of 2004
 Federal Anti-Tampering Act
 Sanitary Food Transportation Act
 Mammography Quality Standards Act (MQSA)
 Bioterrorism Act of 2002
 Public Health Service Act
 Trademark Act of 1946
 Controlled Substances Import and Export Act
45

FDAACTIVITIES
 Broad Responsibilities
 Benefits Vs. Risks
 Safe, Wholesome and
Sanitary Food
 Safe and Effective
Medicine, Biological and
Medicinal Device
 Safe Consumer and
Medicinal Radiation
Products
 Truthful and Informational
Labels
 Safe Cosmetics
Safe and Effective Animal
Drugs
Standards and Regulations
Science, Regulation and
Consumer Protection
Keeping Watch
Safe Manufacturing and
Handling
Monitor for New Risks
Research
Enforcements
46

DRUGS
 Antidepressant Use in
Children, Adolescents, and
Adults
 Buying Medicines Online
 Celexa
 Cialis
 Counterfeit Drugs
 COX-2 Inhibitors (Vioxx,
Bextra, Celebrex)
 Foreign Rx Drugs
 Oxycontin
 Phenylpropanolamine
(PPA)
 Protonix
 Viagra
FOODS
 E. coli East Coast
Outbreaks
 Spinach/E. coli
Information
 Food Safety for Moms-to-
Be
 Food Guide Pyramid
 Hurricane and Food
Safety
 Bioengineered Foods
 Color Additives
 Foodborne Illness
 Holiday Food Safety
 Konjac Candy Recalls
 Mercury in Fish
 Dietary Supplements48

MEDICAL
DEVICES
 Contact Lenses and Eye
Infections
 Decorative Contact
Lenses
 Breast Implants
 Device User Fees
 LASIK Eye Surgery
 Tampons
 Radiation Protection
 Whole Body CT Scans
 Wireless (Cell) Phones
MISCELLANEOUS
Animal Cloning
Antibiotic Resistance
Bioterrorism Act
BSE (Mad Cow Disease)
Buying Medical Products
Online
Counterterrorism
Flu Information
Poison Ivy
Halloween Safety Tips
Marijuana for Medical
Use
Quitting Smoking
SARS
Tattoos & White Oak49

CHALLENGES FACED BY FDA
 Scientific breakthroughs: FDA scientists will need to keep
up with rapidly- advancing technologies in all product areas.
 More sophisticated products: These technologies will
translate into products with new complexities and risks.
 New public health threats: We'll need to be prepared to
respond rapidly to unexpected health risks, such as the threat
of terrorism, tougher strains of antibiotic-resistant bacteria or
more dangerous foodborne illnesses.
 International commerce: Monitoring of imports and
cooperation with foreign regulators will become more
important as international commerce continues to grow.50

 Consumer Information: Finally, today's sophisticated
consumers and the wide availability of information about FDA-
regulated products will challenge us to be sure consumers are
getting the information they need from the right sources.
 Working with Partners to meet Challenges:
As we respond to these challenges and future challenges, we will be
changing our ways of doing business while maintaining our high
standards for consumer protection.
We will work more collaboratively with our partners in government,
industry, health professions, and educational institutions. We are
also asking these partners and the general public what they think
about how FDA can do a better job.
51

USFDA IN INDIA
 In India FDA ensures that food and medical product exported
from India to the US are safe and effective
 Engaging with Indian regulatory authorities to ensure the
timely exchange of information regarding clinical trials of drug
which are marketed in US
 Increased FDA inspection frequency
 Co-ordinating and collaborating on product quality and safety
issues with other Indian government agencies.
52

REFERENCE
www.fda.govt
 www.wikipedia.com
 www.slideshare.net/../usfda-guidelines
 www.slideshare.net/swrk/usfda-guidelines
 www.slideshare.net/hemang-patel/usfda
53

Usfda swatee

More Related Content

What's hot (20)

Viewers also liked (20)

Similar to Usfda swatee (20)

More from Saket Singh (6)

Recently uploaded (20)

Usfda swatee