The US Food and Drug Administration has recommended three user fee programmes that are designed to help speed up the delivery of safe and effective drugs to patients.

Under the programmes, the industry can choose to pay fees to help fund a portion of the FDA’s drug review activities, while the FDA agrees to overall performance goals within a particular time frame. Recommended to Congress by Health and Human Services Secretary Kathleen Sebelius, the programmes include the fifth authorisation of the Prescription Drug User Fee Act (PDUFA), and new user fee programmes for human generic drugs and biosimilar biological products.

FDA Commissioner Margaret Hamburg said, "At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion. Human drug user fees have revolutionised the drug review process in the US since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards."

It is hoped that fees paid by industry will speed up the review of critical prescription drugs and advance the development of drugs for rare diseases.

Caption: User fee programmes are designed to speed up the delivery of drugs to patients. Photo: Martin Allinger.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.