The FDA just unveiled its new, pricier fee schedule to review new drugs
With the new user fee deals signed into law, the FDA unveiled a new increased fee schedule that will apply to biopharmaceutical companies for their prescription drug and biosimilar applications and programs.
For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about $1.2 million, which is about $192,000 more than 2017.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.