answersLogoWhite

0

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency run by the Executive Branch of the American government that makes sure that all food and medical supplies are safe to eat or use before going out to the general public. This was created by president Theodore Roosevelt after the novel by Upton Sinclair called ' The Jungle ' was released, which described the horrors in the meat industry. Questions in this category should include questions about the recall of certain foods and drugs, testing methods used by this agency, and the history of the FDA.

430 Questions

Vitamins that are sold in a health-food store are or is not regulated by the Food and Drug Administration?

is this a subject verb agreement

3a. Vitamins that are sold in a health-food store are not regulated by the Food and Drug Administration.

3b. Vitamins that are sold in a health-food store is not regulated by the Food and Drug Administration.

Who has the authority over who The DEA or the FDA?

The DEA is under the Department of Justice. The FDA is under the Department of Health and Human Services. One does not have authority over the other. There is a Memo of Understanding ( MOU 225-15-011) that describes the relationship, information sharing, and collaborative efforts between the two agencies.

Is keratin treatment fda approved?

Well the FDA says it's in the process of investigating Brazilian Blowout "and similar products. That means its approved by FDA with some conditions on their products that are available in markets and online stores as artbeautyonline.com.

Can you explain the risks of committing a type 1 error in the FDA?

Lukenge Matthew,

lukenmat@gmail.com

UVRI-Uganda.

Type 1 error is a null rejection error (wrongfully rejecting the null which states that there will be no difference in anticipated observations in the study groups). Type II error, however, is the null acceptance error. The consequences of committing a type I error are way more grave compared to type II.

The FDA caters for food and drug regulation meant for human consumption. An example of a null hypothesis is Drug X has no cancerous impact in humans while the alternative will be Drug X has cancerous impact on humans.

Usually the critical value is set at 0.05% but in drugs its at 0.01%, i.e. the researcher has 1% chance of committing type I error. if one performs the statistical tests and comes up with say a Z-score of (0.09) less than 1.65 (0.05%) he/ she will reject the null but assuming this 0.09 was a wrong value supposed to be 2.29 thus supposedly meant to accept the null and therefore not recommending the use of the cancerous drug.

Now, if one wrongly rejected the null, the inferance will be that the drug is good and not cancerous, therefore, this researcher will full blown expose the public to a cancerous drug, however, if he committed a type II where a drug which isnt actually cancerous is rejected on a wrong statistical finding that its cancerous, no one will use the fine drug and probably the pharmacueticals will wrongly loose out but the impact isnt as grave as it would be if a cancerous drug is wrongfully allowed on the market by commiting the type 1 error.

What do you think life in the US would be like if the FDA did not exist?

The FDA is a government agency. If the FDA did not exist, we would all face one of two outcomes. Obviously, there would be no regulation or standard practice in preparation or distribution of foods. This could be a potential danger and possible serious health hazard to everyone. In addition, any drug(over the counter, prescription, legal, illegal, etc.) would be legal and available for whoever. The entire nation would be ill. In the second scenario the FDA would be replaced with a different government-ordained administration, for better or worse. Obviously, there would be differences all around. For the most part, however, this is a very broad question which will be answered many different ways depending on the opinion of the person who responds.

What is the F.D.A. approved chip implanted in hand or forehand?

The Digital Angel chip is the F.D.A. approved chip that is implanted in hand or forehand.

Isoxiprine for sale?

Yes, it is approved by FDA and on the market.

Is stevia an approved FDA alternative sweetener?

Not necessarily. Whole leaf and crude Stevia extracts are currently not considered GRAS (generally recognized as safe) and have not been approved as food additives.

Only specific manufacturers of the highly refined extracts (Rebaudioside A) have been given GRAS status. These companies and products are listed on FDA's website under "GRAS Notices."

What is the full meaning of Nafdac?

national agency for food and drug administration and control.

Why can't a vaccine be developed straight away when you have the Swine Flu?

It takes time to isolate the virus causing the disease and then to capture it and make it reproduce rapidly in a laboratory to enable the development of a vaccine.

Some strains that are captured and tried may not "grow" well and then a different strain needs to be found to use instead. The medium to carry the viral particles to enable inoculation of flu vaccines does not need to be redeveloped for every type of virus grown, and the testing of the medium does not have to be redone for each annual vaccine that is developed. So, in that aspect of drug manufacturing and testing, the new flu vaccines can be developed much more rapidly than other types of medicines and brought to market faster since the testing of the medium doesn't need to be redone each time.

It was actually astonishing how fast the new vaccine for the pandemic swine flu made it to the end user patient, actually. They were very lucky to find the right strain that would grow easily and reproduce especially quickly to enable the vaccine to get to market even sooner than originally anticipated and in time for the 2009-2010 flu season after the start of the pandemic.

What is the Mexican equivalent to the US-FDA?

the equivalent is COFEPRIS Comision Federal para la Protección contra Riesgos Sanitarios

Is platelet rich plasma injection FDA approved?

It's not the PRP that needs approval from the FDA, it is the machine or centrifuge that processes the blood that needs approval. The machine has to go through the FDA to get a 510k clearance for the preparation of platelet rich plasma for human use. From their each company has different procedures that they are cleared for (and some they are not).

What name under which the drug is listed by the US food and drug administration who by federal law names the drug for human use in the US?

I find it very troubling that students are asking people on Answers.com to do their homework for them. There are many who ask health related questions. The failure to study and understand the material to be able to answer these questions will put patients at risk.

Who wants an intellectually lazy doctor, nurse, pharmacist or other health professional making decisions about their life ?

What does Fda on your paycheck mean?

"FDA" on your paycheck typically refers to "Federal Insurance Contributions Act," which is related to Social Security and Medicare taxes. It may also indicate deductions for federal taxes. If "FDA" appears in a different context, it could be specific to your employer's payroll system or a unique abbreviation they use, so it's best to check with your HR department for clarification.

What is the definition of a Raw Material according to the FDA?

FDA does not explicitly define raw material, but depending on your situation, you may actually be looking to use the term component. 21CFR820.3(c) defines component:

Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

Is an herb considered a new dietary ingredient?

In the United States, if an herb had not been marketed as a dietary ingredient in dietary supplements before October 15, 1994, then it would be considered a new dietary ingredient. The burden is on manufacturers and distributors to determine whether or not an herb would be considered a new dietary ingredient and to document that the herb was either in a dietary supplement or marketed for use in dietary supplements before October 15, 1994.

Please see the information on the US FDA website: fda.gov/Food/DietarySupplements/ucm109764.htm