FDA- SEMINAR.pptx

Food and drug administrative in food microbiology

1. FOOD MICROBIOLOGY Food and Drug Administrative (FDA) A.VELKUMAR II M.Sc MMCROBIOLOGY REG NO: 20201232516123 SUBMITTED TO, Dr.C.MARIAPPAN ASSOCIATE PROFESSOR DEPARTMENT OF MICROBIOLOGY SPKC-ALWARKURICHI SEMESTER IV

2. A.VELKUMAR II M.Sc MICROBIOLOGY

3. FDA -- F OOD AND D RUG A DMINISTRATIVE FDA’s Job to see that medicines are medical devices is safe or effective. FDA is Federal science based law enforcement agency mandated to protect public health.

4. FDA FORMED - June 30,1906;115 years ago Preceding agencies Food, Drug and Insecticide Administration (July 1927) Bureau of Chemistry, USDA (July 1901) Division of Chemistry, USDA (Established 1962)

5. This agency approximately 9000 employees they are Scientist Inspectors Medical doctors and other professional

6. HISTORY OF FDA 1848 – Origins to the U.S.Patent and Trademark Office 1862 – Creations of the U.S. Department of Agriculture (Chemical analysis of agriculture products) 1906 – The FDA regulatory functions started and passing of the Pure Food and Drug Act 2008 – in I ndia

7. HOW IS FDA ORGNIZED…? FDA is organized into eight officers and program centres Commissioner's office

8. COMMISSIONERS OFFICE FDA headed by the commissioner of food and drugs. Appointed by the president of United states confirmed by the U.S strand and secures as the president’s decision The officers of the commissioner oversees all of the agencies activities

9. PROGRAM CENTERS FDA is organized into several specialized program canters that are responsible for protecting the public's health. The FDA canters approves products in the biotech and pharmaceutical industries and it’s approval or rejection of a product can have a financial impact

10. U.S. Food and Drug Administration Office of the Commissioner Office of Foods Center for Veterinary Medicine Center for Food Safety & Nutrition Office of Medical Products & Tobacco Center for Devices & Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation & Research Center for Tobacco Products Office of Global Regulatory Operations & Policy Office of Regulatory Affairs Office of Chief Scientist National Center for Toxicological Research Office of Women’s Health Office of Minority Health 4

11. FDA REGULATED PRODUCTS Food Drugs Medical Devices Radiation Emitting Products Vaccines, Blood and Biology's Animal and Veterinary Cosmetics Tobacco Products

12. 1 . FOOD Fish provide  key nutrients  that support a child’s  brain development . Omega-3 (called DHA and EPA) and omega-6 fats Iron Iodine (during pregnancy) Choline Eating fish can provide other  health benefits  too . sodium reduction targets for a broad range of processed, packaged and prepared foods to help reduce the amount of sodium in the U.S. food supply

13. Continue FOOD L imit mercury in the diets of those who are pregnant or breastfeeding and children, many types of fish are both nutritious and lower in mercury.  This chart can help you choose which fish to eat, and how often to eat them, based on their mercury levels.

14. 2 . DRUGS The Centre for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people  Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products . Resources For You Find Information About a Drug FDA Drug Info on Twitter External Link Disclaimer FDA Recall Information on Twitter External Link Disclaimer Receive email updates for Recalls and Drug Shortages                Advances in FDA's Drug Safety Programs  (annual reports) Index to Drug-Specific Information FDA Drug Safety Podcasts

15. 3 . MEDICAL DEVICES Coronavirus (COVID-19) and Medical Devices Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves . NOTE : First Laser-Based Device for IVC Filter Dec 21 – An IVC filter is a small cage-like device inserted into the Interior vena cava (IVC) to capture blood clots.

16. 4 . RADIATION EMITTING PRODUCTS Some consumer electronic devices, such as certain cell phones and smart watches, include high field strength magnets. Recent studies have shown that consumer electronic devices with high field strength magnets may cause certain implanted medical devices to switch to “magnet mode” and suspend normal operations until the magnet is moved away from the medical device

17. 5 . VACCINES, BLOOD & BIOLOGICS Allergenics Allergen Extracts, Allergen Patch Tests, Antigen Skin Test   Blood & Blood Products Blood , Blood Components, Blood Bank Devices, Blood Donor Screening Tests   Tissue & Tissue Products Bone , Skin, Corneas, Ligaments, Tendons, Stem Cells, Sperm, Heart Valves   Vaccines Vaccines for Use in Children and Adults, Tuberculin Testing   Xenotransplantation Transplantation of Non-Human Cells, Tissues or Organs Into a Human Science & Research Research by FDA Staff to Evaluate and Enhance the Safety of Biologic Products

18. 6 . ANIMAL AND VETERINARI Animal Drugs Animals food Animal Medical Device For Consumers For Industry For veterinarians

19. 7 . COSMETICS FDA has received reports of adverse reactions to some “decal,” henna, and “black henna” temporary tattoos. Here is information about the safety of these products and how they are regulated. Some peoples skin sensitive got allergic reactions, Alergic reactions on man hand

20. Continue COSMETICS Allergens in Cosmetics Did you know cosmetic products can provoke allergic reactions in some people? FDA provides information about common allergens found in cosmetic products. Many products we use every day contain fragrances. Some of these products are regulated as cosmetics by FDA . Many other products that may contain fragrance ingredients, but are not applied to the body, are regulated by the  Consumer Product Safety Commission .

21. 8 . TOBACCO PRODUCTS FDA’s Canter for Tobacco Products (CTP) works to ensure a healthier life for every family. New tobacco products may not be legally marketed without authorization from FDA.

22. Drug company develops drug and conducts animal testing Drug company sends an Investigational N ew D rug application (IND) to the FDA with a plan for human clinical trials Drug manufacturer conducts Phase I, II, and III clinical trials on humans Drug company fills out a formal New D rug A pplication (NDA) for marketing approval FDA reviews clinical trial data for drug safety and effectiveness FDA will either approve or deny the drug STEPS TO FDA DRUG APPROVAL

23. FDA DATA BASES or RESOURCES Drugs@FDA National Drug Code (NDC) Directory Orange Book Purple Book Drugs Safety Labelling Changes (SLD) Database Drugs Shortages Approved Risk Evolution and Mitigation Strategies (REMS) Drug Safety Communications MedWatch

24. REFERENCE : https :// www.google.com/search?q=fda+full+form&rlz=1C1CHBF_enIN981IN981&oq=FDA+full&aqs=chrome.0.0i433i512j69i57j0i512l8.5119j0j15&sourceid=chrome&ie=UTF-8 U.S. Food and Drug Administration https://www.fda.gov