FDA

Question: Why is the FDA avoiding medicinal marijuana, it's sold in pharmacies as a regular prescription? Insurance covers it like a regular prescription, but somehow it's not a prescription? Any prescription medicine MUST be FDA approved, the FDA is skirting this issue as more and more states legalize marijuana on the medicinal level, why? Mutt, what about the federal law that says all prescriptions must be FDA approved, one federal law has precedence over another? I guess it's like a riddle, how many states have to legalize it medicinally before the FDA is forced to back it?

Answer: Because medical marijuana is not covered under Federal Law. In fact all of the FDA studies on the stuff have concluded that safer and more effective alternatives exist to treat the medical "conditions" that the marijuana supporters claim to treat. Of course nobody wants the stuff that has been demonstrated to be 'safe and effective' to current scientific standards because it will not get you high.

Question: What is the FDA Compliance and how is it related to software documentation? I have a job interview in the morning for a healthcare solutions IT company. It is a software testing and documentation role. A careers advisor told me I should research documentation for healthcare companies and the FDA Compliance for the interview an be able to talk about this. I was just wondering what the FDA Compliance has to do with software documentation and what i should know going into the interview. Any help greatly appreciated!

Answer: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/default.htm http://www.metricstream.com/solutions/fda_compliance.htm http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133770.pdf http://www.etq.com/biotech/ http://www.etq.com/ http://www.mastercontrol.com/fda/fda_compliance_software.html http://www.bitpipe.com/detail/RES/1266597815_636.html

Question: What are the steps to apply for FDA approval to produce and sell food preservatives? I have a company in another country but want to apply for FDA approval to produce and sell our canned food preservative in the U.S. I checked everywhere on the net but still am confused about it. Please help. Thanks.

Answer: One thing is to check, the other is to ask. Get a hold of someone from the FDA and let them know what you want. Ask to be directed to the appropriate department who can assist you with your importation. Please keep in mind that certain products are not allowed in the US no matter what. Good Luck to you Business Student.

Question: If the FDA hasn't evaluated a drink then can the nutritional facts on it be trusted? I like to drink sugar-free energy drinks, which usualy say that they havent been evaluated by the FDA. So, would the makers be lying about the low calories and low carbs and suff? It says that it has two 10 calorie servings, so can i rely on that to be true?

Answer: usually the terms "low calorie" and such are based on the fact that they have few calories than their high sugar counterparts. There are strict regulations aboiut what can be considered "low" or "reduced". the nutritional information is required by law to accurate but the facts can be deceiving to the consumer. Low calorie doesn't make it any safer because those drinks are full of caffein and other weird things. As far as the FDA goes the product cannot claim to treat, cure or prevent any disease.

Question: The FDA is considering regulating salt. Where does the FDA get its power to regulate a natural substance? As you may know, the FDA is considering whether to regulate sodium chloride (salt). Where does the FDA get its power to regulate private businesses (restaurants and other places that sell food with salt as an ingredient)? Let's say you are a dude who perfected your own private label brand of salsa. You sell it online and you're doing well. Then, the FDA decides to regulate how much salt you can use in your special recipe. It ruins the unique flavor of your salsa and your sales suffer. What gave the FDA power to control a legal and natural substance such as sodium chloride?

Answer: The federal government's straying from the Constitution and the peoples' willingness to accept it. So long as people keep quiet, the fed will weasel around the Constitution in any way they can in support of those with prohibitionist mindsets. Of course, salt will taste just that much better when it is forbidden. If you need any salsa bootleggers, I'm in.

Question: What is the FDA Regulatory status of Capsicum as a topical analgesic in patch form? Cannot seem to find a suitable answer from the FDA. Doing R&D on use with other topical warming and cooling agents in an occlusive gel patch.

Answer: Try looking it up as capsaicin

Question: What's the difference between the FDA and the AMA when it comes to approving diet pills? Heard a recent news report that there's a diet pill that has been approved by the FDA for the first time. How have previous diet pills made it to store shelves w/o FDA approval??

Answer: FDA approves "drugs" ie preparations which have a medical use. Most diet pills are not considered to be drugs, they are "dietary supplements".

Question: Where can I find information about the FDA approval process of drugs, medicine, pharmacological agents? I need to present information on how medicines become approved for use by the FDA. I also could use info on the authority of the FDA and how politics influence it. The steps required for a drug to get approval, regulation of drugs and advertising, etc. Any ideas on good sources for me to look at?

Answer: Here's a diagram of the process http://www.fda.gov/cder/handbook/develop.htm Here's a detailed review of the drug approval application process http://www.fda.gov/cder/regulatory/applications/ As for politics, look up information about the OTC status application for emergency contraception. It's a very interesting but sad history. You can then compare that to the quick approval of Viagra. Let me know if you need any more help. :)

Question: Why doesn't the FDA approve some herbal remedies but approves pharmaceuticals with known side effects? Some herbal remedies are not approved for human consumption even though they have been used traditionally by humans for centuries with very little side effects. One of the herbs I’ve taken works better than a well know medication which has been know to cause bad side effects. Why won’t the FDA approve some things that have well documented histories of human use, but have no problem approving newly developed synthetics? I'm just glad I found this something that works for me. I can see this remedie becoming band at some point. I say what it is but I don't want to draw attention The particular herb I take is sold as not for human consumption because it isn't FDA approved. However the alkaloids in this herb have been scientifically proven, and well documented to work the same on certain receptors in the brain without a common side effect to a synthetic commonly prescribed for this condition.

Answer: I guess they have vowed not to approve anything which can possibly cure you, just the things which can make you dependent upon more chemicals so all you are good for is to keep on taking those drastic chemicals which they have the audacity of calling Medicine. What else do you expect from FDA(Fools, Dolts and A**holes) ? They can't bite the hand which feeds them my friend, or can they. You can check on their authenticity by the number of paid goons who are giving all of you THUMBS DOWN to even answer against them on this friendly forum. correct me if I am wrong. Take Care and God Bless.

Question: What is the acceptable mortality rate for medicines according to the FDA? Suppose some medicine is invented that increases the well-being and happiness of takers, but also results in a mortality rate of X percent. What is the value of X that would mean the drug is banned by the FDA?

Answer: None. Seriously, they do not have a single mortality rate cut off. Mortality rate is only a small part of more complicated FDA safety and efficacy measurements. One example is called Quality Adjusted Life Years (QALY - pronounced "kwal-ee"). QALYs are calculations of the effect a disease (or the treatment for a disease) have on the overall length, value, cost and enjoyment of a person's life. You can compare your QALY before taking the medicine to afterward. If your QALY improved the medicine may be worthwhile (even if it doesn't greatly reduce the mortality rate). In the final approval process a committee of scientists, pharmacologists, physicians and public health specialists review these measurements. They vote on granting FDA approval. In summary, a mortality rate higher than the control (non-medicated) population will most likely keep a medicine from being approved, but there is no single cut-off number.

Question: What can I do with an FDA in interior design job wise? Hi,I am in the UK and am planning to complete an fda in interior design. However I don't know what my prospects will be with that. How likely is it that Ill get a good career out of it right away? Or will I get nothing? I'd appreciate any comments from anyone who knows more about me on this. Thanks.

Answer: Online Executive Recruitment Firm

Question: What is the diffrence between a FDA and a Degree? Is a FDA a foundation degree. Is it lower than a degree. Can you get a good job from a FDA degree? Is a FDA charged at £1,225 or £3,145 for students in birmingham What is the diffrence between a FDA and a Degree? Which are you likely to get a better job, a degree or a FDA? A FDA is charged at the same value as a degree, i think it is diffrent from a foundation degree- level 0 FDA is level 1. Is it for dump students and not so clever students

Answer: A FdA is a foundation degree The FdA courses normally run parallel to the BA as many students do a 1 year top up course to bring them up to a BA. So they tend to do exactly the same work and have the same syllabus. A bonus for the FdA is that it's normally 2 years long, and at the end of it you will have a foundation degree. After you have this you can do a 1 year top up year to bring you up to a BA degree (proper/full degree). If you were to do the BA, and drop out in the 3rd year you would come away with nothing, but if you do the FdA, you will always have the FdA qualification already. Level 0 is lower than a FdA. If a student doesn't have good grades, I think they have to do a level 0 course first before doing the FdA. (I think)

Question: How do you check herbal ingredients with the FDA? I'm looking to find out about some herbal ingredients and whether or not they meet the FDA's requirements, such as white peony root and poria cocos. But I can't seem to find any FDA-related info on these, or where to find out on the FDA website. Can someone tell me how to check herbal ingredients with the FDA? The other ingredients are Astragalus root, atractylodes rhizome, and codonopsis.

Answer: sorry , the FDA only approves poisonous substances that harm people they cant profit off of herbs unless they mess them up making medicines out of them

Question: How are manufactured cigarettes in compliance with FDA regulations? Can you find the information on FDA regulations and how manufactured cigarettes are in compliance? Thank you!

Answer: The FDA allows a certain amount of poison stuff. Did you realize that virtually everything is toxic. [A central concept of toxicology is that effects are dose-dependent; even water can lead to water intoxication when taken in large enough doses, whereas for even a very toxic substance such as snake venom there is a dose below which there is no detectable toxic effect.] Different people tolerate different substances to different degrees. [Aspirin overdose can be acute or chronic. In acute poisoning, a single large dose is taken; in chronic poisoning, higher than normal doses are taken over a period of time. Acute overdose has a mortality rate of 2%. Chronic overdose is more commonly lethal with a mortality rate of 25%; chronic overdose may be especially severe in children.[102] Toxicity is managed with a number of potential treatments including: activated charcoal, intravenous dextrose and normal saline, sodium bicarbonate, and dialysis.]

Question: How do you get product approval from FDA? I own a trading company. I plan to import some plastic bags for food packaging from China. I need to file for product approval from FDA before my merchandise can be sold here. How do I go about doing this? What are the necessary steps to do? Please help me on this.

Answer: There are companies that will help with this ... it's pretty complicated. http://www.fdaregistrar.com

Question: How to be a FDA Agent to help companies in other country to export to the USA? Hello, I just want to know the process to be a FDA agent to connect USA with companies in my country in north Africa Also, does FDA provide any training in Food Science to be a certified food manager? Thanks All, N.S Sandry, I was not asking about online business..Thanks though!

Answer: You need to contact the FDA to check if there are any programs they have to promote foreign companies.