The FDA
regulates facilities that manufacture OTC medications.
Which US government agency is responsible for regulating medications?
The Food and Drug Administration (FDA)
is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
What was the first US law that regulated medicine?
The first general pure food and drug law at the federal level was not enacted until 1906 with the passage of
the Pure Food and Drugs Act
.
Which government agency is responsible for making sure medications are safe to use quizlet?
FDA Mission
The Food and Drug Administration
is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Which of the following statements best characterizes synergism?
The statement best describes the synergistic interaction effect:
an interaction between two or more medicines that increases their effectiveness
.
What is the meaning of Bfad?
Bureau of Food and Drugs
. (BFAD) with regulatory. functions over food, drugs, medical devices, cosmetics.
Who approves drugs in America?
The U.S. Food and Drug Administration (FDA)
is the federal agency responsible for labeling medications and supplements. However, the approval process is different for prescription and for over-the-counter medications.
Why does the government regulate drugs?
Most governments around the world impose regulations on pharmaceutical companies, in
an effort to protect their public from harmful drug effects
. These regulations often prolong the process for bringing new pharmaceuticals to market.
When did drugs require FDA approval?
Congress passes The Federal Food, Drug, and Cosmetic (FDC) Act of
1938
, which requires that new drugs show safety before selling. This starts a new system of drug regulation.
In what decade were drugs in the US first regulated by requiring a prescription from a medical doctor?
1820
Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States. 1848 Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas.
Which organization in the United States is responsible for ensuring that all medicines are safe and effective quizlet?
Terms in this set (10)
What is
the Food and Drug Administration
(FDA)? an agency of the United States Department of Health and Human Services whose principal purpose is to enforce the Federal Food, Drug and Cosmetic Act. and that all these products are correctly labeled and packaged.
What is the role of the FDA quizlet?
for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs
, vaccines and other biological products, and medical devices and also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products …
Which organization is responsible for regulating tobacco quizlet?
The FDA
also regulates tobacco products.
What causes drug synergism?
In pharmacology, drug synergism happens
when the effects of two or more different kinds of drugs are amplified when they are administered jointly
. Their impact is greater than their combined effects. For instance, drug A produces an effect of 30% while drug B produces an effect of 20%.
What is drug synergism?
Synergism, Synergy.
An interaction between two or more drugs that causes the total effect of the drugs to be greater than the sum of the individual effects of each drug
.
What is synergism antagonism and potentiation?
Synergistic effects are
when the sum of the effect is more than the two individual chemical effects combined
. For this effect, 2 + 2 = 10. Antagonistic effects are when the net effect of the combined chemical interaction is zero. … Potentiating effects are when one chemical enhances the toxic effect of another chemical.
What is Republic Act No 5921?
5921. An
Act Regulating the Practice of Pharmacy and Setting Standards of Pharmaceutical Education in the Philippines
and for Other Purposes. Be it enacted by the Senate and House of Representatives of the Philippines in Congress.
Who regulates prescription drugs?
The Center for Drug Evaluation and Research (CDER) is
the FDA Center
responsible for overseeing the drug program which includes over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Visit the Human Drugs Import page for more information on import requirements.
What is Republic No 9711?
9711)
AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS BFAD BY ESTABLISIHING ADEQUATE TESTING LABORATORIES AND FIELD
OFFICES.
Why is RA 8203 important?
Special Law on Counterfeit Drugs (Republic Act No. 8203). An
Act Prohibiting Counterfeit Drugs Providing Penalties for Violations and Appropriating Funds Therefor
. This Act, consisting of 14 sections, aims at protecting human and animal health through provisions against counterfeit drugs.
Who approves drugs for FDA?
The drug sponsor
formally asks FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.
Who decides FDA approval?
FDA approval of a drug means that data on the drug’s effects have been reviewed by
CDER
, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
How does the government regulate the pharmaceutical industry?
The Food and Drug Administration (FDA) is the U.S. government agency
charged with ensuring the safety and efficacy of the medicines available to Americans
. This tragedy led to the Food, Drug, and Cosmetic Act of 1938, which required that drugs be proven safe prior to marketing. …
Who regulates pharmaceutical industry in European Union?
The European Medicines Agency (‘EMA’)
is an Agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.
How are medicines regulated?
The Medicines and Healthcare products Regulatory Agency
regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.
When did the government start regulating drugs?
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.
Which of the following was the first attempt by the government to control and regulate the manufacturer distribution and sale of drugs?
The regulation of drugs by the federal government began with
the Pure Food and Drug Act of 1906
, which prohibited the interstate commerce of adulterated and misbranded drugs. 3 The law did not require drug manufacturers to demonstrate safety or effectiveness prior to marketing.
What was the Harrison Act of 1914 quizlet?
what was the 1914 Harrison “Narcotics” act?
A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax.
Which organizations is responsible for regulating tobacco?
To protect the public and create a healthier future for all Americans, the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), signed into law on June 22, 2009, gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.
How is the FDA agency set up?
It consists of
the Office of the Commissioner and four directorates
overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
The FDA
regulates medical devices sold in the United States to assure their safety and effectiveness. Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems.
Which organization is responsible for regulation tobacco?
FDA’s Center for Tobacco Products
regulates the manufacturing, marketing, and distribution of tobacco products to protect public health.
What are some other organizations that supply health information to the public?
The Centers for Disease Control and Prevention, National Cancer Institute, National Women’s Health Information Center
, American Public Health Association, Consumer Reports, and American Cancer Society are some organizations that supply health information to the public.
Which US government agency is responsible for regulating medicines?
The U.S. Food and Drug Administration (FDA)
is the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices.
Which US government agency is responsible for regulating medications ??
The Food and Drug Administration (FDA)
is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
Which organization in the United States is responsible for ensuring that all medicines are safe and effective?
The Food and Drug Administration (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.
Which of the following is regulated by FDA?
The FDA regulates a wide range of products, including
foods
(except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic …
Which of these US federal agencies oversees the use of medical mobile apps MMA in research?
According to the FDA, what are medical mobile apps (MMAs)? … Which of these U.S. federal agencies oversees the use of medical mobile apps (MMA) in research?
U.S. Food and Drug Administration (FDA)
What type of categories does the FDA use to classify regulated devices?
What does the FDA regulate?
FDA is responsible for protecting public health by regulating
human drugs and biologics, animal drugs, medical devices, tobacco products
, food (including animal food), cosmetics, and electronic products that emit radiation.
Where are most drugs metabolized quizlet?
Most drug metabolism that takes place in
the liver
is performed by the hepatic microsomal enzyme system, aka the P450 system.
What is potentiation pharmacy?
Potentiation is
an interaction between two or more drugs or agents resulting in a pharmacologic response greater than the sum of individual responses to each drug or agent
, e.g. combination of sedative drugs with alcohol.
What is summation in pharmacology?
When two drugs with similar mechanisms are given together, they typically produce additive effects
. This is also referred to as summation. However, if the effect of two drugs exceeds the sum of their individual effects, this is referred to as potentiation or synergism.
