What are the 4 steps to making new medicine?

Answer 1

procurement

processing

manufacturing

distribution

Next Answer

There are really more than only four steps but combined we have:

• Laboratory development of a new drug.
• Preclinical testing - Laboratory and animal testing to determine safety of drug
• Clinical Trials on people - Test drug on volunteers to determine if drug is both effective and safe on people, This is performed in three or four phases with an increasing test population of healthy patients or sick patients and a longer trial period each time, testing the drug for effectiveness and for safety and side effects.
• FDA reviews all results and determines if all the testing and trials were done properly, if the drug is safe enough and good enough to be used by patients, its benefits outweigh the risks of using it, for what illnesses the drug is approved and which population segments should be included or excluded from drug approved usage (children, elderly, males, females, etc.). The FDA has to approve the proposed drug labeling and if manufacturing process has sufficient controls to insure effective and safe drug production.
• The pharmacy company manufacturers the product, informs the medical community, and distributes it to pharmacies to be used by patients.