usfda swatee
TRANSCRIPT
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.
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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 FDA Activities What Is New Challenges faced by
FDA USFDA in India References
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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.
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DEFINATIONUSFDA:- The U.S. Food and Drug Administration (FDA) is
an agency of the US Department of Health and Human ServicesThe 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.
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What is the need?
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OBJECTIVES
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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.
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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.
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COMPONENTS OF USFDA
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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
CBERCBER regulates biological products to advancing the public
health through innovative regulations that ensures;the safetyeffectiveness 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.
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PRODUCTS REGULATED BY CBER Blood. Devices. Vaccines. Cellular therapy. Tissue. Xenotransplantation products. Human Tissue & Cellular products. Allergenics.
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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
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CDERThe 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.
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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 & Programs16
CFSANThe 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.
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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.
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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
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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).
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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)
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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
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NCTR
Centre of Excellence
Toxicoinformatics
Phototoxicology
FunctionalGenomics
Structural Genomics
Hepatotoxicology Metabolomics Proteomics
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OCThe 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
ORAOffice 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.
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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)
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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 CosmeticsAn 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
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III. Shelf Life No regulations or requirements under current united states law Manufacturers have the responsibility to determine shelf life
for products
IV. Cosmetic LabelingThe 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
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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.
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WHO MAKES UP FDA?The FDA consists of employees drawn from a wealth of science
and public health professions.
Biologists, physicians, chemists, biomedical engineerstoxicologists, pharmacologists, veterinarians, and specialists in thepublic health education and communication.
FDA employs approximately 11,516 people who work in locations around the United States.
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FDA MISSION
Mission Statement
FDA Strategic
Plan
FDA Customer Service
Standards
What FDA
Regulates
What FDADoes Not
Regulate
Laws Enforced
By FDA
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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.
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FDA STRATEGIC PLAN
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FDA CUSTOMER SERVICE STANDARDS
I. Customers
II. Health professionals
III. Regulated industry
IV. Other government agencies
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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
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Health ProfessionalsTimely 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.
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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 devices 39
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
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WHAT FDA DOES NOT REGULATEAdvertisingAlcoholConsumer ProductsDrugs of AbuseHealth InsuranceMeat and PoultryPesticidesRestaurants and Grocery StoresWater
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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 farmsAnimal feed processorsFDA 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.
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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.
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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
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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
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FDA ACTIVITIES
Broad ResponsibilitiesBenefits Vs. RisksSafe, Wholesome and
Sanitary FoodSafe 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 RegulationsScience, Regulation and
Consumer ProtectionKeeping WatchSafe Manufacturing and
HandlingMonitor for New RisksResearchEnforcements
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WHAT IS NEW ?
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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 IllnessHoliday Food Safety Konjac Candy Recalls Mercury in Fish Dietary Supplements
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MEDICAL DEVICES
Contact Lenses and Eye Infections
Decorative Contact Lenses
Breast Implants Device User Fees LASIK Eye Surgery Tampons Radiation ProtectionWhole Body CT Scans Wireless (Cell) Phones
MISCELLANEOUS
Animal Cloning Antibiotic Resistance Bioterrorism Act BSE (Mad Cow Disease) Buying Medical Products
OnlineCounterterrorism Flu Information Poison Ivy Halloween Safety Tips Marijuana for Medical Use Quitting Smoking SARS Tattoos & White Oak 49
CHALLENGES FACED BY FDAScientific 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.
Consumer information50
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.
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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.
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REFERENCEwww.fda.govt www.wikipedia.com www.slideshare.net/../usfda-guidelines www.slideshare.net/swrk/usfda-guidelines www.slideshare.net/hemang-patel/usfda
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THANK-YOU
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