Question

A pharma company is awaiting FDA approval for a new drug. It is their first and their only product. They have nothing else in the pipeline. Can you provide an approximate for the beta of the company during the FDA approval process.

Answer 1

Answer:

It would not be advisable to promote a product before they approve it since you do not know if they will validate it and you will spend on marketing for pleasure

Whether or not a new drug requires approval The FDA's dependence on the new drug fits an over-the-counter (OTC) monograph. OTC monographs specified conditions under which the FDA has predetermined that a medication will be safe and effective. Once an OTC monograph is finalized, medication devices can market OTC medications that conform to the monograph without FDA approval. The FDA also uses the application at its discretion to allow certain medications to be marketed without approval if they conform to tentative final monographs.

If a new medication does not meet a monograph, it will require FDA approval. To obtain FDA approval, drug manufacturers must conduct laboratory tests, animal and human clinical analyzes, and submit their information to FDA. The FDA will review the information and may then approve the medication if the agency determines the benefits of the medication plus the risks to the intended use. Marketing a new drug that is not compliant with an OTC monograph and without an FDA test is considered as marketing a new unapproved medication, which is a prohibited act under the Food, Drug and Cosmetic Act (FD&C Act).