USFDA

GUIDELINES OF USFDA

1. US FDA REGULATING AUTHORITY OF US

2. WHAT IS US FDA ? (united state food & drug administration agency) It is an agency of the united states department of health and human services (HHS) 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 o pening office in foreign countries including China ,India , Costa Rica , Chile , B elgium and UK.

3. 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.

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

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

6. FUNCTIONS 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.

7. 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.

8. FDA PROGRAMMES FOR MONITORING 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

9. DOCKET 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.

10. 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.

11. THANKS