"Click"
Time is precious as FDA seriously needs it. The FDA systems or more specifically, the FDA drug administration is still lacking a proper system to navigate them as a whole. "Time" certainly is one of their main key for them to solve the organization's structure. However, FDA is not the only one who needs time, other drugs, therapy, and medical devices industries are still needing time for their items to be in used and approved by the FDA. All medical equipment's, drugs, food, and products (related to consumption) must have gone through the FDA before it to appears in the our shelf. Selling such items without the approval of the FDA can lead to public in state of unsafety and endanger. In the case of this article, they talked about the closing of a unapproved stem cell treatment prescription drug . The FDA is shutting it because the information of the treatment didn't went to them before it was allowed to be utilized. The hospital was against it ( they were mad at FDA for restricting too much) and says that it can cure or proceed quicker of the drugs result, kind of like a clinical trials. But, under the FDA evaluation, the drug is still considered a shut down drug, even if is for the purpose of testing, a drug will be a drug that's what they are trying to say (the FDA), any drugs will certainly contains an ingredients that can be harmful to us. An unapproved drug shouldn't be used unless is agree by the consent of the patient.
Tuesday, October 31, 2017
Friday, October 27, 2017
FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders
FDA Unveils Ramped-up Regulatory Initiatives for Drug Compounders
Statements FDA made, some initiatives that FDA stated in effort to put more work on regulating compounded drugs (contain more than one chemical ingredients and are prescribed at the exact dosage and amount to patients).
The implements FDA are trying to press:
1) requires information of the drugs, list of chemicals, experiments, trials, and data to ascertain it safety.
2) Request information of the facility to conduct investigation.
3) Allow intergovernmental interrogate and coordinates on the compounded drugs to show FDA are engaging in issue matter.
Statements FDA made, some initiatives that FDA stated in effort to put more work on regulating compounded drugs (contain more than one chemical ingredients and are prescribed at the exact dosage and amount to patients).
The implements FDA are trying to press:
1) requires information of the drugs, list of chemicals, experiments, trials, and data to ascertain it safety.
2) Request information of the facility to conduct investigation.
3) Allow intergovernmental interrogate and coordinates on the compounded drugs to show FDA are engaging in issue matter.
FDA’s Authority to Regulate Off-Label Promotion
FDA’s Authority to Regulate Off-Label Promotion
I think this article is interesting to understand the power of FDA and how they proceed on certain actions. In the case of this article, is about the off labeled drugs and it promotion sales in public. The off label drugs are drugs with little proof and low scientific evidences supported, the risk of intake such drugs are high and dangerous, because they often are mislabeled or aren't meant to cure. On the hand of the FDA, they do have the authority to press charge and regulate the off-label drugs, however, other principals laws from the federal can interfere with the FDA regulation. The way off-labeled can get away from it is by carefully label their products and provide little evidence. FDA under the federal laws, they do have the rights to ban and remove certain drugs but on the off-label drugs, the way they handle the situation is by squeeze play (processing something with little effort).
I think this article is interesting to understand the power of FDA and how they proceed on certain actions. In the case of this article, is about the off labeled drugs and it promotion sales in public. The off label drugs are drugs with little proof and low scientific evidences supported, the risk of intake such drugs are high and dangerous, because they often are mislabeled or aren't meant to cure. On the hand of the FDA, they do have the authority to press charge and regulate the off-label drugs, however, other principals laws from the federal can interfere with the FDA regulation. The way off-labeled can get away from it is by carefully label their products and provide little evidence. FDA under the federal laws, they do have the rights to ban and remove certain drugs but on the off-label drugs, the way they handle the situation is by squeeze play (processing something with little effort).
Subscribe to:
Posts (Atom)