About FDA - Food and Drug Administration (2023)

About FDA

  • Mandate
  • Mission
  • Vision
  • Function
  • Goals
  • FDA Quality Policy
  • FDA Core Values
  • Organization Structure
  • FDA Management Team
  • FDA Inspectorate Team

As a regulatory agency under the Department of Health, the Food and Drug Administration, created under Republic Act No. 3720, series of 1963, as amended by Executive Order 175, series of 1987, otherwise known as the “Food, Drugs and Devices, and Cosmetics Act”, and subsequently Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”, is mandated to ensure the safety, efficacy or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health which require regulations as determined by the FDA.

Among others, the FDA is also mandated to enforce theprovisions of the following laws:

(Video) Who is the U.S. Food and Drug Administration FDA

  • RA9502, or The Universally Accessible Cheaper and QualityMedicine Act of2008
  • RA 6675, orThe Generics Act Of 1988,
  • RA 10918, or The Pharmacy Law,
  • RA 9211, or The Tobacco Regulation Act of 2003
  • RA 7394, or The Consumer Act of the Philippines
  • RA 7581/10623, or The Price Act
  • RA 10611, or The Food Safety Act of 2013
  • RA 8172, or The ASIN Law,
  • RA 8203, or The Special Law on Counterfeit Drug
  • RA 8976, or The Food Fortification Law
  • RA 9165, or The Comprehensive Dangerous Drugs Act
  • RA 9257, or The Expanded Senior Citizens Act of 2003
  • PD No. 881, or The Household Hazardous Act
  • EO No. 51, or The Milk Code of the Philippines
  • RA 10354, or The Responsible Parenthood and Reproductive HealthBill of 2012
  • PD 856, or The Code of Sanitation of the Philippines

To guarantee the safety, quality, purity, efficacy of products in order to protect and promote the right to health of the general public.

The Food and Drug Administration to be an internationally recognized center of excellence in health product regulation by 2026.

In order to protect and promote the right to health of the Filipino people and to establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems, the FDA shall perform the following functions as provided by existing laws:

  • To establish safety or efficacy standards and quality measures for foods, drugs and devices and cosmetics and other health product;
  • To undertake appropriate health manpower development and research, responsive to the country’s health needs and problems;
  • To assume primary jurisdiction in the collection of samples of health products;
  • To analyze and inspect health products;
  • To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;
  • To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA;
  • To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality;
  • To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person;
  • To issue cease and desist orders motu propio or upon verified complaint for health produts, whether or not registered with the FDA Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed;
  • To order the ban, recall, and/or withdrawal of any health product, after due process, found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization;
  • To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products;
  • To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products;
  • To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA;
  • To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products;
  • To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and
  • To exercise such other powers and perform such other functions as may be necessary to carry out its duties and responsibilities.
  • To protect and promote the right to health of the Filipino people by ensuring the safety, efficacy, quality, and purity of foods, drugs, devices, and cosmetics, and
  • To establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems.

Ensure the safety, efficacy, quality and purity of health products by fostering integrity, transparency and excellence; developing and maintaining evidence-based standards and policies, in a healthy and safe work environment.

Bawat Kawani ng FDA, Lingkod Bayani"

EXCELLENCE - Pagiging Mahusay refers to our Highest degree of professionalism and superior work standard in discharging one's duty

LEADERSHIP - Mahusay na Pamumuno refers to the management thinking that all employees in all levels of public service who, at their best, care and do something about the challenges faced by theFDA

INTEGRITY - Pagiging Matapat refers to our consistent adherence to strong and ethical principles, wether alone or in public

(Video) DeSantis: Florida sues FDA for information over proposal to import cheaper drugs from Canada

PATRIOTISM - Pagiging Makabayan refers to our love for our country and fellowmen

SPIRITUALITY - Pagiging Maka-Diyos refers to our belief, love and faith for a Higher Being

About FDA - Food and Drug Administration (1)

About FDA - Food and Drug Administration (2)Dr. Oscar G. Gutierrez, Jr., MPA, PCVPH Officer-In-Charge-Director GeneralOffice of the Director General
  • [emailprotected]
About FDA - Food and Drug Administration (3)Atty. Ronald R. De Veyra, MBA, CESO IIDeputy Director General for Internal ManagementOffice of the Deputy Director General for Internal Management
  • [emailprotected]
About FDA - Food and Drug Administration (4)Arnold G. Alindada, Dr. HCM, MPH, RMT Director II Officer-In-Charge Deputy Director General for Field Regulatory Operations OfficeOffice of the Deputy Director General for Field Regulatory Operations Office
  • [emailprotected]
About FDA - Food and Drug Administration (5)Engr. Ana Trinidad F. RiveraDirector IVCenter for Cosmetics and Household Urban Hazardous Substances Regulation and Research
  • [emailprotected]
About FDA - Food and Drug Administration (6)Jesusa Joyce N. CirunayDirector IVCenter for Drug Regulation and Research
  • [emailprotected]
About FDA - Food and Drug Administration (7)Engr. Ma. Cecilia C. MatienzoDirector IVCenter for Device Regulation, Radiation and Health Research
  • [emailprotected]
About FDA - Food and Drug Administration (8)Pilar Marilyn M. PagayunanDirector IVCenter for Food Regulation and Research
  • [emailprotected]
About FDA - Food and Drug Administration (9)Jocelyn E. Balderrama, RPh., MBADirector IIICommon Services Laboratory
  • [emailprotected]
About FDA - Food and Drug Administration (10)Atty. Emilio L. Polig, Jr.Director IIILegal Services Support Center
  • [emailprotected]
About FDA - Food and Drug Administration (11)Estrellita B. Pastolero, MGMOfficer-In-ChargeFood and Drug Action Center
  • [emailprotected]
About FDA - Food and Drug Administration (12)Irene Florentino-Fariñas, RPh., MD, MNSADirector II, Officer-In-ChargePolicy and Planning Service
  • [emailprotected]
About FDA - Food and Drug Administration (13)Gomel C. Gabuna, LlB, MDM, CESEDirector IINorth Luzon Cluster, Field Regulatory Operations Officer
  • [emailprotected]
About FDA - Food and Drug Administration (14)Carolyn P. CustodioDirector II, Officer-In-ChargeSouth Luzon Cluster, Field Regulatory Operations Office
  • [emailprotected]
About FDA - Food and Drug Administration (15)Rica Reina C. AumentadoDirector II, Officer-In-ChargeVisayas Cluster, Field Regulatory Operations Office
  • [emailprotected]
About FDA - Food and Drug Administration (16)Deborah S. LegaspiDirector IIMindanao East Cluster, Field Regulatory Operations Office
  • [emailprotected]
About FDA - Food and Drug Administration (17)Sharon Rose P. GarciaDirector II, Officer-In-ChargeMindanao West Cluster, Field Regulatory Operations Office
  • [emailprotected]
DRUGS GDP and GMP INSPECTORS
RFO CAR
GMPGDP
Nadia D. Navarro, FDRO II **Nadia D. Navarro, FDRO II
Rochelle T. Bayanes, FDRO II
Giovanni G. Monang, FDRO II

RFO 1

GMPGDP
Jeffrey J. Gamboa, FDRO II **

Veronica F. Obille, FDRO III/Regional Supervisor

Airene Z. Barlin, FDRO II
Jeffrey J. Gamboa, FDRO II
Imelda B. Calmada, FDRO II

RFO 2

GMPGDP
Janelle L. Lim, FDRO II **

Alegria G. Ong, FDRO III & RFO II Supervisor

Shanida Joy O. Singson, FDRO II **Janelle L. Lim, FDRO II
Shanida Joy O. Singson, FDRO II
Consuelo R. Ricablanca, FDRO II
Dianne Cristelle S. Maningas, FDRO II
Krisha Melody G. Lavadia, FDRO II
Rose Agatha D. Pagalilauan, LO III

RFO 3

GMPGDP
Clarissa A. Mendoza, FDRO III *

Virginia P. Timbol, FDRO IV & RFO III Supervisor

Gia Heida N. Bognot, FDRO II **Alona O. Palmares, FDRO III
Clarissa A. Mendoza, FDRO III
Gia Heida N. Bognot, FDRO II
Ma. Concepcion P. Canilao, FDRO II
Benedict R. Balajadia, FDRO II
Imee S. Patriarca, FDRO II
Ronald D. Tiglao, FDRO II
Kristie Ann T. Abuel, FDRO II
Diana Mae C. Castro, FDRO I
Krinessa S. Manlapat, FDRO II

RFO NCR

(Video) The Food and Drug Administration Explained

GMPGDP
Ma. Lynn Rachelle A. Natividad, FDRO III *Fleurdelis E. Mendiola, Pharmacist IV
Rioriza A. Ortilano, FDRO III *Archie M. Balilo, FDRO II
Ma. Lolita B. Abo-ol, FDRO III *Gian Angelo L. Cruz, FDRO II
Marissa C. Fajardo, FDRO III *Theresa A. Dizon, FDRO II
Don Bryan A. Orendain, FDRO III *Cristal Jule B. Dolendo, FDRO II
Ma. Suzette R. Sta. Clara, FDRO III *Maureen D. Mabulay, FDRO II
Angeli B. Casala, FDRO III *Gladys Jane M. Martinez, FDRO II
Frances Glorie D. De Luna, FDRO III *Mark Anthony A. Polpol, FDRO II
Mary Angeline V. Francisco, FDRO II *Sarah Y. Manucdoc, FDRO I
Michael E. Galang, FDRO II *Clare Louise Reyes, FDRO I
Lelian B. Indac, FDRO II *
Jackerwin R. Maur, FDRO II *
Cristy Hanna V. Mendoza, FDRO II *
Rowena K. Velasco, FDRO II *
Irene A. Dimayacyac, FDRO II *

RFO 4A

GMPGDP
Cristian V. Martinez, FDRO II
Richard P. Gerinas, FDRO II

RFO 4B

GMPGDP
Ephraim Joseph D. Dela Cruz, FDRO II **Luzvimin G. Atienza, FDRO III
Lilibeth D. Mayor, FDRO II
Ephraim Joseph D. Dela Cruz, FDRO II

RFO 5

GMPDrug GDP
Edwin E. Castillo, Jr., FDRO II **Emily M. Espinas, FDRO III
Rica D. Morales, FDRO II **Silvia C. Lopez, FDRO II
Ma. Dolores V. Alegre, FDRO II
Edwin E. Castillo, Jr., FDRO II
Elias J. Almajeda, FDRO II
Ma. Jehan A. Icamen, FDRO II
Rica D. Morales, FDRO II
Rachelle Flor Faustino-Agsolid, FDRO II
Hazel Ann A. Alagaban, FDRO I

RFO 6

GMPDrug GDP
Mary Jade S. Tan, FDRO II
Ma. Gina G. Joquico, FDRO II
Maricon G. Dimatulac, FDRO II
Mabel U. Concepcion, FDRO II
Gladys Mae V. Sanchez, FDRO II
Arlene G. Punsalan, FDRO II
Gemma T. Tabiano, FDRO II

RFO 7

GMPDrug GDP
Ma. Salome R. Largo, FDRO II **Sarah C. Oriol, FDRO III
Irish B. Samar, FDRO I **Therese Antoniette V. Cuyos, FDRO II
Ma. Salome R. Largo, FDRO II
Christa Marie L. Baritua, FDRO II
Lucrecia O. Matugas, FDRO II
Vicky R. Sibala, FDRO II
Diana A. Tindoy, FDRO I
Krissa Joy E. Elardo, FDRO I
Irish B. Samar, FDRO I

RFO 8

GMPGDP
Benczint Benedikt C. Ortega, FDRO III **Benczint Benedikt C. Ortega, FDRO III
Ma. Christine T. Ty, FDRO II
Pinky A. Bantanos, FDRO II
Khin Janique M. Lagonoy, FDRO I
Laura Marie C. Carcueva, FDRO II
Sheryl Mae C. Gente, FDRO II
Emelyn O. Mercado, FDRO II
Ma. Cielo R. Yee, FDRO II

RFO 9

GMPDrug GDP
Gladys Valerie Kaye R. Angeles, FDRO II **Kathrina U. Hassan, FDRO III
Gladys Valerie Kaye R. Angeles, FDRO II

RFO 10

GMPDrug GDP
Lorelie Joy A. Acha, FDRO II **Lorelie Joy A. Acha, FDRO II
Anthonette K. Melgo, FDRO II
Desie A. Maghamil, FDRO II
Ma. Auralynn V. Macalisang, FDRO II

RFO 11

GMPDrug GDP
Eba Marie Antonette W. Inis, FDRO IV & RFO XI Regional Supervisor **Phyllis Irene Pineda – FDRO III
Jan Paul S. Cano, FDRO II **Araceli V. Arceo, FDRO II

RFO 12

GMPGDP
Mayen P. Abdullah, FDRO II **Nicanora D. Rabara, FDRO III & RFO XII Regional Supervisor
Reshyl Jean T. Morano, LO III **Mayen P. Abdullah, FDRO II
John David O. Garduque, FDRO II
Maria Celestina B. Pascual, FDRO II
Jeselle L. Mationg, FDRO II

RFO 13

GMPGDP
Keith Bryan Vincent R. Angeles, FDRO II **Perla B. Alvizo, FDRO III/ Regional Supevisor
Lucille Glenda T. Bug-os, FDRO II **Keith Bryan Vincent R. Angeles, FDRO II
Lucille Glenda T. Bug-os, FDRO II
Virginia K. Delani, FDRO II
Richel B. Prado, FDRO II
Potenciana A. Santiago, FDRO II

* - Full time GMP Inspector

(Video) Andreas KELLER, US Food and Drug Administration (FDA), Multi-Commodity Foods Director

** - Part time GMP Inspector

(Video) OVERVIEW OF THE FOOD AND DRUG ADMINISTRATION (FDA)

FAQs

Why the FDA is important? ›

The FDA is responsible for protecting and promoting public health through regulation and supervision of food safety, dietary supplements, tobacco products, over-the-counter and prescription animal and human medications, vaccines, medical devices, etc.

What is Food and Drug Administration means? ›

Listen to pronunciation. (... ad-MIH-nih-STRAY-shun) An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled.

What are the 5 phases of FDA approval? ›

Information For
  • Step 1: Discovery and Development.
  • Step 2: Preclinical Research.
  • Step 3: Clinical Research.
  • Step 4: FDA Drug Review.
  • Step 5: FDA Post-Market Drug Safety Monitoring.
4 Jan 2018

What has the FDA done? ›

FDA regulates about 78 percent of the U.S. food supply.
...
FDA-Regulated Products and Facilities.
ProgramImports ($Billions)Exports ($Billions)
Human and Animal Drugs$93.62$31.67
Human Food and Cosmetics$158.90$122.90
Medical Devices$68.01$58.69
Tobacco$1.58$1.05
4 more rows
17 Aug 2022

Who approves FDA drugs? ›

A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

What are FDA regulations? ›

FDA develops regulations based on the laws set forth in the Food, Drug, and Cosmetic Act (FD&C Act) or other laws – including the Family Smoking Prevention and Tobacco Control Act – under which FDA operates. FDA regulations have the full force of law.

What is FDA and their responsibility? ›

Monitors, evaluates and ensures compliance of manufacturers, distributors, advertisers and retailers of processed foods, drugs and other related products to health rules and regulations and standards of quality.

Who controls the FDA? ›

Department of Health and Human Services

How FDA regulates drugs? ›

First, FDA reviews the safety and effectiveness of new drugs that manufacturers2 wish to market in the United States; this process is called premarket approval or preapproval review. Second, once a drug has passed that threshold and is FDA-approved, FDA acts through its postmarket or postapproval regulatory procedures.

Is the Covid vaccine FDA approved? ›

On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older.

What are the different types of FDA approval? ›

To give patients earlier access to critical new drugs, four rapid FDA approval designations exist — priority review, breakthrough therapy, accelerated approval, and fast track.

What is required for FDA approval? ›

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

How many drugs are FDA approved? ›

There are over 19,000 prescription drug products approved for marketing.

What is the FDA drug approval process? ›

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

How many types of drugs are there? ›

DREs classify drugs in one of seven categories: central nervous system (CNS) depressants, CNS stimulants, hallucinogens, dissociative anesthetics, narcotic analgesics, inhalants, and cannabis.

Why do drugs need to be FDA approved? ›

Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality or whether their label is complete and accurate.

How long FDA approval takes? ›

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

Does all food have to be FDA approved? ›

FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).

What is FDA final rule? ›

The Final Rule states that the responsible party may authorize the National Institutes of Health (NIH) to publicly post clinical trial registration information for an applicable device clinical trial of a device product that has not been previously approved or cleared by the U.S. FDA.

What 3 things does the FDA regulate? ›

FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. FDA also has the responsibility in maintaining the safety of our nation's food supply (human and animal), cosmetics, and products that emit radiation.

Are FDA requirements law? ›

FDA regulations are also federal laws, but they are not part of the FD&C Act. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).

Why is the FDA important in healthcare? ›

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”

What is the role of FDA in pharmaceutical industry? ›

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA.

Does the FDA regulate food? ›

The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture. The regulatory requirements may depend on the specific nature of your product.

Who created the FDA? ›

Food and Drug Administration

Where is the FDA located? ›

FDA headquarters facilities are located in Montgomery and Prince Georges Counties in Maryland. Many FDA employees are consolidated at the White Oak Campus located in Silver Spring, MD. Remaining headquarters employees are housed in numerous additional buildings located across the Washington, D.C. area.

Why was the FDA created? ›

The United States Food and Drug Administration (FDA) was first created to enforce the Pure Food and Drug Act of 1906. In this capacity, the FDA is charged with protecting the health of the US public, to ensure the quality of its food, medicine, and cosmetics.

Is Johnson and Johnson vaccine FDA approved? ›

The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older.

Which vaccine is the safest? ›

The Pfizer and Moderna vaccines are strongly recommended as safe and effective at preventing serious illness or death from COVID-19. From December 2020 to December 2021, about 470 million doses of COVID-19 vaccine have been given in the U.S.

Can you get Covid twice? ›

Reinfection with the virus that causes COVID-19 means a person was infected, recovered, and then later became infected again. After recovering from COVID-19, most individuals will have some protection from repeat infections. However, reinfections do occur after COVID-19.

What is FDA classification? ›

The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device's safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III.

What does FDA registered? ›

Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared” or “Approved,” and they cannot use the FDA logo in marketing or labeling the device.

How do you verify FDA approval? ›

To find out if a drug is approved by FDA, consumers can use two different Internet sites:
  1. Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. ...
  2. The FDA "Orange Book" contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
21 Sept 2017

What is the FDA approval rate? ›

Overall success rates from Phase I to FDA approval is nearly 9%. This number is comprised of lead and secondary indications. When separated, lead indications have close to a one in seven rate of approval and secondary indications have a rate of one in 30.

What was the first FDA medication? ›

1937. Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

When was the FDA started? ›

Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act.

How many FDA phases are there? ›

There are three phases to complete in the clinical trial process before a sponsor can submit their treatments* to the FDA for consideration to be sold on the market. Each stage of a clinical trial has its own purpose in ensuring that a treatment is safe and effective for use by the public.

What are the 3 main drugs? ›

Drug categories
  • depressants – slow down the function of the central nervous system.
  • hallucinogens – affect your senses and change the way you see, hear, taste, smell or feel things.
  • stimulants – speed up the function of the central nervous system.
21 Jun 2021

What are 4 main drugs? ›

The four types of drugs include:
  • Depressants These are drugs that slow or depress the functions of the central nervous system and brain. ...
  • Stimulants: Drugs that accelerate up the central nervous system are called stimulants. ...
  • Opioids: Drugs that are used to suppress physical pain are called analgesics or opioids.

What are the 4 main type of drugs? ›

Grouping Drugs Based on Effect
  • Opioids.
  • Stimulants.
  • Depressants.
  • Hallucinogens.
15 Feb 2022

What is FDA and their responsibility? ›

Monitors, evaluates and ensures compliance of manufacturers, distributors, advertisers and retailers of processed foods, drugs and other related products to health rules and regulations and standards of quality.

How does the FDA protect public health? ›

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

What is the FDA and why was it created? ›

The United States Food and Drug Administration (FDA) was first created to enforce the Pure Food and Drug Act of 1906. In this capacity, the FDA is charged with protecting the health of the US public, to ensure the quality of its food, medicine, and cosmetics.

How does the FDA provide protection of your rights? ›

The FDA: Protecting Consumers and Patients

The FDA is there to protect consumers and patients and ensure their safety by regulating and approving products, issuing recalls and safety notices, and alerting us to health scams and other health threats.

Who controls the FDA? ›

Department of Health and Human Services

How FDA regulates drugs? ›

First, FDA reviews the safety and effectiveness of new drugs that manufacturers2 wish to market in the United States; this process is called premarket approval or preapproval review. Second, once a drug has passed that threshold and is FDA-approved, FDA acts through its postmarket or postapproval regulatory procedures.

Who leads the FDA? ›

Dr. Robert Califf

Why is the FDA important to healthcare? ›

FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Does the FDA regulate food? ›

The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture. The regulatory requirements may depend on the specific nature of your product.

What is the role of FDA in pharmaceutical industry? ›

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA.

What drugs does the FDA regulate? ›

The following is a list of traditionally-recognized product categories that fall under FDA's regulatory jurisdiction; however, this is not an exhaustive list.
...
Biologics, including:
  • vaccines for humans.
  • blood and blood products.
  • cellular and gene therapy products.
  • tissue and tissue products.
  • allergenics.
18 Jan 2022

What was the first FDA approved drug? ›

1937. Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

When did FDA approval begin? ›

Although it was not known by its present name until 1930, FDA's modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.

What authority does the FDA have? ›

Videos

1. Webinar: Introduction to US Food and Drug Administration (FDA 101)
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2. FDA's New Food Safety Law
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3. What Does FDA Regulate?
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4. FDA's Food Contact Substance (FCS) Notification Program
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