When using information for your reseach paper, you need to know if the author is a credible source. Ask yourself, Is the author an expert in this particular field of study? Does the article give any background information on the author? Does the author have advanced degrees in that subject area(e.d.
FDA is responsible for protecting the public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our nationÃ¢â¬â¢s food supply, cosmetics, dietary supplements, and products that give off radiation.
Orphan drug status does not mean that the drug is approved for use. It means that the drug company qualifies for certain benefits (described above) and needs to continue through the FDA process. Effectively, this means that the regulators and the manufacturers have made this drug a priority for Rett syndrome. The data has been reviewed by the FDA in regards to the claims of the drug and the FDA approves what Neuren has done. * 2 This is important for Rett syndrome because it means the FDA has looked at the data on how NNZ-2566 [Trofinetide] works and they like what they see.