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FDA evolves application process

By Nick Taylor , 15-Jul-2008

The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives.

Firstly the agency has called time on its "approvable" and "not approvable" responses to drug applications, replacing it with a "complete response". This brings the approval response into line with biologic license applications. The "complete response" will detail specific flaws in the application and recommendations as to how to achieve approval. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research (CDER), said: "These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form. "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."


A desire not to scare investors has been cited as a reason for the change. According to financial website Motley Fool the old system was "hated by most investors" as it gave too broad a definition, giving little idea of how close to approval a drug was. Implementation of the new letters is due to occur on August 11. The FDA documentation on the change can be found here . FDA launches electronic drug registration The FDA has initiated a voluntary pilot programme enabling pharmaceutical manufacturers to electronically file drug establishment registration and listing information.


By implementing electronic registration the FDA believes it can make "significant improvements in the timeliness and accuracy of the information received". In addition, the FDA has said new system will create a more accurate bank of information. The agency believes this will improve its ability to identify possible safety issues and respond to emergencies such as drug recalls and shortages. Electronic filing will be initially rolled out on a voluntary basis, with the FDA planning on ending the transition period on June 1 2009. After this date all filings must be made electronically.


Guidance has been issued by the FDA to smooth the transition for manufacturers. The relevant documents can be found here and here .

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