It takes up to 10 years of extensive laboratory testing to determine initial safety and efficacy of new therapeutics. After these studies, an Investigational New Drug (IND) application is filed for FDA review.
If approved, the drug will go into clinical trials.
The FDA carefully reviews the data to weigh
the benefits and risks of the potential medicine.
If deemed safe and effective, it is approved for patients.
When the NDA or BLA has been approved, the medication is manufactured and distributed. Manufacturing facilities adhere to FDA regulated standards to ensure safety and quality of medicines.
In 2011 the industry supported
in U.S. economic output.8
The biopharma sector supports
jobs across the U.S.9
After a new medicine reaches patients, companies conduct post-approval studies to monitor safety and side effects in a larger patient population, and gain further understanding of the medicine's potential uses.
Often it takes years of additional research and use by patients for the full value of a medicine to be recognized.
“Incremental advances can add up to transformative changes.” — Dr. Siddhartha Mukherjee10