this presentation will help to understand organization and function of USFDA.

1. FDA
OR
USFDA
BY
HEMANG PATEL
YOGESH PATEL
JAIMIN PATEL
TEJAS GOSWAMI
ICRI- AHMEDABAD MSc. CT & CR (2011-13) 1

2. ۩ Scientific, Regulatory, Public Health Agency
۩ Mission is to protect and promote public health.
http://www.fda.gov/
Authority to regulate medical devices
Federal FD&C Act
Established regulatory controls for medical devices
(May 28, 1976)
21 CFR Parts 800-1299.
2

3.  Clinical chemistry and  General and plastic surgery
clinical toxicology  General hospital and
 Hematology and pathology personal use
 Immunology and  Neurological
microbiology
 Ophthalmic
 Anesthesiology
 Orthopedic and physical
 Cardiovascular
 Dental
medicine
 Ear, nose and throat  Obstetrical and
 Gastroenterology & urology gynecological
devices  Radiology
Medical Device Definition in Sec 201(h) of the FD&C Act
3

4.  Goal: Implement the National Commission’s
recommendations
 1981: 21 CFR Part 50 (Informed Consent Regulations)
 1981: 21 CFR Part 56 (IRB Regulations)
◦ Subpart A: General provisions
◦ Subpart B: Organization and Personnel
◦ Subpart C: IRB Function and Operations
◦ Subpart D: Records and Reports
◦ Subpart E: Administrative Actions for Noncompliance
 2001: 21 CFR Part 50, Subpart D – Additional
Safeguards for Children in Clinical Investigations
4

5. ۩ The Food and Drug Administration (FDA),
established in 1930 as a part of the US Department of
Health and Human Services (DHHS), regulates
products accounting for roughly 25% of the United
States gross national product.
5

6. ۩ Virus-Toxin Law of 1902 (also referred to as the Biologics
Control Act)
۩ Food and Drug Act of 1906
۩ Federal Food, Drug and Cosmetic Act [FD&C Act] of 1938:
۩ Durham-Humphrey Amendment of 1951:
۩ Kefauver-Harris Amendment of 1962:
۩ Medical Device Amendments of 1976:
۩ Anti-Tampering Regulations (1982):
6

7. ۩ The U.S. Food and Drug Administration (FDA) is
an agency of the US Department of Health and
Human Services (DHHS) that is responsible for the
safety regulation of:
◦ most types of foods ◦ dietary supplements
◦ drugs ◦ biological medical products
◦ vaccines ◦ radiation-emitting devices
◦ blood products ◦ veterinary products
◦ medical devices ◦ cosmetics
7

8. ۩ The FDA also enforces other laws, notably Section
361 of the Public Health Service Act and associated
regulations, many of which are not directly related to
food or drugs.
۩ These include sanitation requirements on interstate
travel and control of disease on products ranging
from certain household pets to sperm donation
for assisted reproduction.
8

9. ۩ 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.
9

10. Office of
Food and Drug Combination
Administration Products
Center for Veterinary National Center for
Devices Toxicological Research
Center for Biologics Center for Food Safety and
Evaluation and Research Applied Nutrition
Center for Devices and Center for Drug Evaluation
Radiological Health and Research
10

11. 11

12. Office of In-Vitro
Office of Device
Diagnostic
Evaluation
Devices & Safety
Office of Center for Devices Office of
Surveillance and Science &
& Biometrics Radiological Health Technology
Office of Health
Office of
& Industry
Compliance
Programs
12

13. U.S Food and drug administration
Commissioner
Center for Food Safety and Applied
Nutrition (CFSAN)
Center for Drug Evaluation and
Research (CDER)
Center for Biologics Evaluation and
Research (CBER)
Center for Devices and Radiological
Health (CDRH)
Center for Veterinary Medicine (CVM)
Center for Veterinary Medicine (CVM)
13

14. ۩ 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.
14

15. As of Oct. 1, 2009, FDA employs the following numbers
of people in its centers/offices:
Center for Biologics Evaluation and Research
946
(CBER)
Center for Drug Evaluation and Research (CDER) 2,889
Center for Devices and Radiological Health (CDRH) 1,203
Center for Food Safety and Applied Nutrition
877
(CFSAN)
Center for Tobacco Products (CTP) 194
Center for Veterinary Medicine (CVM) 436
National Center for Toxicological Research (NCTR) 217
Office of the Commissioner (OC) 859
Office of Regulatory Affairs (ORA) 3,895
Total 11,516
15

16. ۩ They provide FDA with independent advice from
outside experts on issues related to human and
veterinary drugs, vaccines and other biological
products, medical devices, and food.
۩ In general, advisory committees include a chair,
several members, plus a consumer, industry, and
sometimes a patient representative.
۩ Additional experts with special knowledge may be
added for individual committee meetings as needed.
although the committees provide advice to the
agency, FDA makes the final decisions. 16

17. ۩ People nominated as scientific members must be
technically qualified experts in their field, such as,
 Clinical medicine
 Engineering
 Biological and physical sciences
 Biostatistics
 Food sciences
17

18. ۩ They also must have experience interpreting and
analyzing detailed scientific data, and understanding
its public health significance.
۩ For Example……
۩ people nominated for the Drug Safety and Risk
Management Advisory Committee in the Center for
Drug Evaluation and Research should be
knowledgeable in risk communication, risk
management, drug safety, and medical, behavioral,
and biological sciences as they apply to risk
management and drug abuse.
18

19. ۩ Foods, except for most meat and poultry products,
which are regulated by the U.S. Department of
Agriculture.
 Food additives
 Infant formulas
 Dietary supplements
 Human drugs
 Vaccines, blood products, and other biologics
 Medical devices, from simple items like tongue
depressors, to complex technologies such as heart
pacemakers.
19

20.  Electronic products that give off radiation, such as
microwave ovens and X-ray equipment.
 Cosmetics.
 Feed, drugs, and devices used in pets, farm animals,
and other animals.
 Tobacco products.
20

21. ۩ FDA does not regulate:
 advertising (except for prescription drugs, medical
devices, and tobacco products).
 alcoholic beverages
 some consumer products, such as paint, child-
resistant packages, baby toys, and household
appliances (except for those that give off radiation)
 illegal drugs of abuse, such as heroin and marijuana.
 health insurance.
 meat and poultry (except for game meats, such as
venison, ostrich, and snake).
 Restaurants and grocery stores.
21

22. ۩ FDA shares the responsibility for regulating these
products with other government agencies:
 Pesticides (FDA, the U.S. Department of
Agriculture, and the Environmental Protection
Agency regulate these).
 Water (FDA regulates the labeling and safety of
bottled water, while the Environmental Protection
Agency develops national standards for drinking
water from municipal water supplies).
22

23. ۩ The FDA is the U.S. Government agency
that oversees most foods and medical
products.
۩ Its job is to make sure that:
 Food is safe, healthy, and clean.
 Medicines and medical devices are reasonably
safe and effective.
 Cosmetic products are safe.
 Animal foods and drugs are safe.
 Food and medical products have proper labels.
23

24. ۩ The programs for safety regulation vary
widely by the type of product, its potential
risks, and the regulatory powers granted to the
agency.
۩ The FDA regulates most products with a set of
published standards enforced by a modest
number of facility inspections. Inspection
observations are documented on Form 483.
24

25. ۩ The Food and Drug Modernization Act states that
the FDA has 4 roles:
 To promote health by reviewing research and
approving new products.
 To ensure foods and drugs are safe and properly
labelled.
 To work with other nations to “reduce the burden of
regulation”.
 To cooperate with scientific experts and consumers
to effectively carry out these obligations.
25

26. ۩ The FDA regulates an enormous number of companies. As of
November 2000, the FDA's Official Establishment Inventory,
the FDA's database of establishments regulated by the agency,
included 135,885 firms including these:
 64,756 food and cosmetic firms
 37,839 device and radiological health firms (of which
roughly 9,500 are mammography facilities)
 17,625 human drug firms
 7,702 animal drug and feed firms
 4,223 biologic firms
 2,320 storage warehouses
 1,420 miscellaneous food-related facilities
26

27.  The FDA inspects facilities to ensure compliance with the
Food, Drug and Cosmetic Act (FD&C Act) and can seek
criminal or civil penalties against both companies and
individuals when its regulations are violated.
 Intentionally defrauding or misleading the FDA or violating
the act may be a felony, but the concept of strict liability
means that even those who unintentionally violate the act
can be prosecuted for missed manors because intent is not
required to violate the law. Missed meaner violations may
result in fines of up to $1,000 and up to 1 year in prison.
27

28. ۩ FDA inspects manufacturers or processors of
FDA-regulated products to verify that they
comply with relevant regulations.
۩Inspected include:
 vaccine and drug manufacturers
 blood banks
 food processing facilities
 dairy farms
 animal feed processors
28

29. ۩ 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.
 foreign manufacturing and processing sites for
FDA- regulated products that are sold in the
United States.
 Imported products at the border. 29

30. ۩ 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.
۩ FDA makes available to the public certain
frequently requested records of inspections in
an electronic reading room. You would need to file
a Freedom of Information request to obtain other
records.
30

31. ۩ A recall is when a product is removed from the
market or a correction is made to the product
because it is either defective or potentially harmful.
۩ Sometimes a company discovers a problem and
recalls a product on its own. Other times a
company recalls a product after FDA raises
concerns.
31

32. ۩ Review of FDA inspectional guides
 Investigations Operations Manual (IOM)
 Compliance Program Guidance Manuals(CPGM)
 Compliance Policy Guides(CPG)
 Inspection Technical Guides
۩ Review of firm’s Establishment Inspection
Report (EIR), Responses to FDA Form 483 etc.
۩ Planning of inspections.
32

33. ۩ FDA Form 482: Notice of inspection.
۩ FDA Form 483: Inspectional observations.
۩ FDA Form 484: Receipt for physical evidence
(e.g., samples) , but not for documentary
evidence (e.g., label, copy of records…).
33

34. •Developing a comprehensive action plan that optimizes
the use of resources to achieve HHS and FDA goals for
public Health and safety as well as developing and
implementing technology solutions.
•Partnering with programs and industry to provide the
innovative information technology that makes it possible
to collaborate across government and globally
maintaining a secure environment in which security
privacy and confidentiality are addressed per
U.S.Government laws regulations . 34

35. ۩ It is FDA program of on-site inspections to ensure the
quality and integrity of the data submitted to the
agency from regulated clinical trials of investigational
drugs, devices, and biologics.
۩ Inspections are made both in the U.S. and
internationally at clinical investigator sites,
institutional review boards (IRBs), and sponsors.
۩ (e.g., pharmaceutical, medical device, and biologic
companies, including monitors and contract research
organizations or CROs working under the sponsor). 35

36. ۩ Inspections are conducted by the
following FDA Centres under the BIMO
program:
 CDRH – FDA Centre for Devices and
Radiologic Health.
 CDER – FDA’s Centre for Drug Evaluation
and Research.
 CBER – Centre for Biologics Evaluation
and Research.
 CVM – FDA’s Centre for Veterinary
Medicine.
36

37. ۩ Following each BIMO inspection, FDA
classifies the overall findings under one of
three possible categories:
I. NAI ( No Action Indicated)
II. VAI (Voluntary Action Indicated)
III.OAI (Official Action Indicated)
37

38. ۩FDA conducted 1024 total BIMO inspections in
2007, about the same as the prior year’s 1100
inspections. Half of all inspections in 2007 were
classified NAI.
۩ Of this total number of inspections in 2007:
636 were of clinical investigators (52% were
NAI, 40% were VAI, 8% were OAI).
367 by CDER
183 by CDRH
77 by CBER
9 by CVM 38

39. ۩221 were of IRBs (51% were NAI, 47% were
VAI, 2% were OAI):
101 by CDER
92 by CDRH
28 by CBER
۩88 were of Sponsors (54% were NAI, 24% were
VAI, 22% were OAI):
23 by CDER
53 by CDRH [usually higher due to larger
number of small device companies doing 1st
clinical trial]
12 by CBER 39

40. ۩ CDRH’s routine inspections focused on paediatric
devices and drug-eluting stents in 2007 and, in 2008,
on implantable orthopaedic products and
cardiovascular devices.
۩ Between 2000 and 2005, FDA inspected only 1%
of all clinical trial sites and 75% of the inspections
were reviews of already-completed trials for data
verification purposes pursuant to a marketing
clearance application. Less than 40% of IRBs were
inspected during that period.
40

41. ۩ More recently, FDA has intensified its commitment to
this area and the number of inspections will
undoubtedly rise. Areas of focus:
 Informed Consent – content, timing, documentation.
 Protocol Compliance – inclusion/exclusion deviations,
patient schedule.
 IRB reporting – notifications for protocol violations, Serious
Adverse Events (SAEs), maintenance of ongoing approval.
 Disclosure and proper documentation of adverse events at
the clinical trial site .
 Drug/Device accountability .
 Delegation of investigator responsibility to sub-investigators
and other staff .
 Foreign clinical trial sites. 41

42. ۩ Each FDA Center has oversight of inspections of
research related to the product(s) it regulates
۩ Inspections are usually conducted by Office of
Regulatory Affairs field investigators
Field inspectors are NOT specifically assigned to
CDER
All Field inspectors are responsible for conducting
inspections for all centers (CBER, CDER, CDRH,
CFSAN, etc.)
42

43. 800
723 690
700 672 647 667 674
600 549 556
Spon
500 CI
400 IRB/RDRC
300 BIOEQ
200 GLP
100
0
FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08
43

44. ۩ Investigational New Drug Forms (IND)
 FDA 1571 Investigational New Drug Application
 FDA 1572 Statement of Investigator
 Instructions for completing FDA forms 1571 and 1572.
۩ New Drug Application Forms (NDA)
 Form FDA-356h Application to Market a New Drug,
Biologic, or An Antibiotic Drug For Human Use
 Form FDA-3397 User Fee Cover Sheet
 Form FDA-3331 New Drug Application Field Report
44

45. ۩ Abbreviated New Drug Application Forms
(ANDA) for Generic Drug Products
Form FDA-356h Application to Market a New
Drug, Biologic or An Antibiotic Drug For
Human Use.
 Guidance for industry: providing regulatory
submissions in electronic format –general
consideration.
45

46. ۩ Orphan Drug Products (for rare diseases and
disorders)
There is no form, but there is a prescribed format for
application for orphan drug status. The section from the
regulations that describes the format can be found on
this website on the The Orphan Drug Act and Related
Law and Regulation page.
۩ Electronic Regulatory Submission & Review (ERSR)
 Regulation and Instructions For Submitting Drug
Application Electronic This webpage provides for
information on CDER's program to enable the electronic
submission of regulatory information to the Center and
the review of it by CDER staff. 46
.

47. ۩ FDA Form Distributions Page. includes
links to:
Certification: Financial Interest and Arrangements of
Clinical Investigators.
Disclosure: Financial Interest and Arrangements of
Clinical Investigators.
MedWatch: FDA Medical Product Reporting Program
– Voluntary.
MedWatch: FDA Medical Products Reporting Program
– Mandatory.
For electronic form submissions, see Electronic
Regulatory Submissions and Review.
47

48. ۩ There are several ways you can report problems to
FDA:
Call the FDA Consumer Complaint Coordinator.
Report a Serious Medical Product Problem Online
Report by Mail: Use postage paid Form FDA 3500
Report by Fax
Report by Phone
 Report a vaccine-related illness or injury to the Vaccine
Adverse Event Reporting System (VAERS).
48

49. To report complaints about pet food (and other
animal feed), all the FDA Consumer Complaints
Coordinator.
 Report complaints online related to FDA- regulated
Clinical Trials.
 Report to FDA’s MedWatch program any product
problems or unexpected side effects (adverse events)
that occur while using drugs, medical devices, dietary
supplements, infant formulas, cosmetics, and blood
products and other biologics (except for vaccines)
either online, by regular mail, by fax, or by phone.
49

50. To find the part of FDA that addresses your area of
concern, see Contact FDA.
You may also contact FDA with your comments or
questions
•by e-mail webmail@oc.fda.gov
•by mail to Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002
•by telephone at 1-888-INFO-FDA (1-888-463-6332),
which is the main FDA phone number for general
inquiries
•by contacting the FDA Public Affairs Specialist for
your geographic region 50

51. 51

52. Posted by AAHRPP on Monday, January 23,2012
۩ In 2011, (FDA) issued
five warning letters to
IRBs. None of the five was
from an Association for the
Accreditation of Human
Research Protection
Programs (AAHRPP)
accredited organization.
۩ Since 1996, the FDA has
issued 108 warning letters
to IRBs. 52

53. 53
Posted by attilacsordas on February 28, 2009

54. 54
fdaimports.com

55.  Insupport of the
agency's mission
to promote and
protect the
public health,
FDA's Strategic
Plan focuses on
four strategic
goals: 55

56.  Goal 1: Strengthen FDA for Today and
Tomorrow
 Goal 2: Improve Patient and Consumer
Safety
 Goal 3: Increase Access to New Medical
and Food Products
 Goal 4: Improve the Quality and Safety of
Manufactured Products and the Supply
Chain
56