How long does it take for FDA to approve a drug?

The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe.Click to see full answer. Beside this, what is the FDA process for approving a drug?A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring. Data gathered during the animal studies and human clinical trials.Subsequently, question is, how long does it take for a drug to go through clinical trials? There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage. But this time span varies a lot. There are many factors that affect how long it takes for a drug to be licensed. Considering this, how much does it cost for the FDA to approve a drug? Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health.How long does it take to get ANDA approval?However, under the next iteration of GDUFA, which will take effect in FY2018, ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission. This is compared to the 42- to 44-month average approval time before GDUFA was in place.