US FDA

[email protected]

2. It is an agency of the united states department
of health and human services (DHHS)
Its headquarter located at White Oak,
Maryland
The agency also has 223 field offices and13
laboratories located throughout the 50 states of
USA.
FDA started opening office in foreign countries
including China ,India , Costa Rica , Chile ,
Belgium and UK.

3. Responsible for regulating and supervising
the safety of foods, dietary supplement,
biologicals, medical products, vaccines,
blood products, medical devices, radiation
emitting devices, veterinary products and
cosmetics. FDA also ensure that these
products are honestly, accurately and
informatively represented to the public.

4. FDA to regulate above mentioned areas has following
organisational bifurcation for effective implementation.
6 PRODUCT CENTER:
CBER (Centre for biologics evaluation & research)
CDRH (Centre for devices & radiological health)
CDER (Centre for drug evaluation & research)
CFSAN (Centre for food safety & applied nutrition)
Centre for tobacco products
Centre for veterinary devices
ONE RESEARCH CENTRE:
NCTR (National centre for toxicological research)
2 OFFICES:
ORA (Office of regulatory affairs) AND OCI (Office of Criminal
Investigations)

7. Center for Biologics Evaluation and Research
(CBER)
946
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
(CFSAN)
877
Center for Tobacco Products (CTP) 194
Center for Veterinary Medicine (CVM) 436
National Center for Toxicological Research (NCTR) 217
Office of the Criminal Investigations (OCI) 859
Office of Regulatory Affairs (ORA) 3,895
Total 11,516
As of Oct. 1, 2009, FDA employs the following numbers
of people in its centers/offices:

8. o Food
oDrugs
oMedical devices
oVaccines, blood and biologicals
oAnimal and veterinary
oCosmetics
oRadiation emitting products
THAT DOES NOT REGULATE:
oAdvertising – Federal trade commission
oAlcoholic beverages – Treasury department’s Bureau of Alcohol,
Tobacco.
oDrugs abuse - Drug enforcement administration
oHealth insurance – Health care financing administration
oMeat and poultry – Agriculture’s food safety and inspection service
oRestaurant and grocery stores – Local county health department
oPesticides – FDA and environmental protection agency

9. Protecting the public health by assuring that
food are safe , sanitary and properly labelled
Veterinary drugs and vaccines, biological
product, medical devices which are intended
for human use are safe and effective
Protect the public from electronic product
radiation
Regulating tobacco products
Assuring cosmetic products are safe
Provide the accurate science based
information.

10. CDER evaluates safety and effectiveness of drug
In vitro-in vivo testing of new drug by the company
Check and submit investigation report
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, drug is approved
for sale
After launching the drug , the FDA monitors its
performance

11. MEDWATCH : It is the FDA safety information and adverse
event reporting program.
Its alert provide timely new safety information on human
drugs , medical device and other biologicals
Its alert contain actionable information that may impact
both treatment and diagnostic choices for health care
professional and patient.
RESOURCES -
Report a serious medical product problem online
Reporting unlawful sales of medical products
Current drug storage
Index to drug specific information
Identifying recalled product
Provide guidelines to drug safety terms

12. FDA maintains a public record of proposed regulations
Encourages public participation in the federal rule
making process by alloying consumers to view and
comment on proposed action
FDA considers these comments when it draws up a final
rule or regulations.
DRUG WITHDRAWL AND MARKET
WITHDRAWL :
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 in their
products and recall that product on its own basis other
time company recalls a product after company raises
concerns over any issues related to the drug.

13. 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.

14. In support of the
agency's mission
to promote and
protect the
public health,
FDA's Strategic
Plan focuses on
four strategic
goals:
14

15. 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

16. TGA – Therapeutic Goods Administration
Responsible for the regulation of therapeutic
goods in Australia.
Therapeutic goods Act 1989, implemented on
15 Feb 1991
Products with therapeutic claim must be
entered in ARTG.
ARTG is a computer database of information
about TG approved for supply in or exported
from Australia.
TGA is unit of FDHA (federal department of
health & ageing.

17. Therapeutic goods
Any goods represented or taken to be for
therapeutic use unless excluded/included
under section 7 of TGA 1989.
REGULATION OF THERAPEUTIC GOODS:
1. Premarket assessment – QSE evaluation
A.Higher risk level – AUSTR – QSE
B.Lower risk level – AUSTL – QS
2. Licensing of manufacturers – GMP
3. Post market vigilance – testing & monitoring