USFDA

US FDA
REGULATING AUTHORITY OF US

WHAT IS US FDA ?
(united state food & drug administration
agency)
O It is an agency of the united states department
of health and human services (HHS)
O Its headquarter located at White Oak,
Maryland
O The agency also has 223 field offices and13
laboratories located throughout the 50 states
of USA.
O FDA started opening office in foreign countries
including China ,India , Costa Rica , Chile ,
Belgium and UK.

RESPONSIBILTIES OF
USFDA:
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.

ORGANISATION OF USFDA
FDA to regulate above mentioned areas has following
organisational bifurcation for effective implementation.
6 PRODUCT CENTER:
O CBER
O CDRH
O CDER
O CFSAN
O Centre for tobacco products
O Centre for veterinary products
ONE RESEARCH CENTRE:
O NCTR
2 OFFICES:
O ORA AND OCI

WHAT DOES FDA REGULATES:
o Food
o Drugs
o Medical devices
o Vaccines, blood and biologicals
o Animal and veterinary
o Cosmetics
o Radiation emitting products
THAT DOES NOT REGULATE:
o Advertising(except for prescription drugs ,medical devices and tobacco
products)
o Alcoholic beverages.
o Illegal drugs of abuse such as Heroin.
o Health insurance
o Meat and poultry
o Restaurant and grocery stores.

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

EVALUATION PROCESS
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.

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

DOCKET
O FDA maintains a public record of proposed regulations
O Encourages public participation in the federal rule making
process by alloying consumers to view and comment on
proposed action
O FDA considers these comments when it draws up a final rule or
regulations.
O DRUG WITHDRAWL AND MARKET WITHDRAWL:
O When a product is removed from the market or a correction is
made to the product because it is either defective or potentially
harmful
O 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.

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

USFDA

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USFDA