Saundra Middleton

	When generic drug manufacturers and related industry submit written inquiries to the Food and Drug Administration (FDA) requesting information on a specific element of a generic drug development or certain post approval submission requirements, the inquiries are referred to as “controlled correspondence.” Controlled correspondence are labelled as 

Until October 2018, these inquiries could only be submitted by emailing the Office of Generic Drugs as outlined in the 

Controlled Correspondence Related to Generic Drug Development

	Submission of controlled correspondence via the email method involved data entered manually by FDA staff. As part of FDA’s ongoing effort to modernize interactions with industry, FDA launched the CDER Direct NextGen Collaboration Portal (the Portal).

 Effective October 2018, FDA’s Center for Drug Evaluation and Research completed enhancements to the Portal so that controlled correspondence can now be received, managed, and tracked online. The Portal allows for more efficient processing of the controlled correspondence and provides “one-stop-shop” access to a prospective applicant’s controlled correspondence request history.

	Handling controlled correspondence through the Portal allows greater consistency, faster triage, simplified acknowledgement, and easier tracking. Fully integrated with CDER’s internal work management systems, the Portal’s expandable cloud capability will also accommodate future growth. After reviewing a request for information via controlled correspondence, FDA sends the requestor a response that can be accessed through the Portal. This central location for submissions and related communications offers a chronological view of all communications and documents.

	The Portal also streamlines FDA’s review of controlled correspondence by providing real-time status updates and notifications about controlled correspondence submissions to FDA personnel. Streamlining the review process for the thousands of controlled correspondence inquiries received each year saves time and aids FDA and industry in developing generic drugs that meet FDA’s Generic Drug User Fee Amendments obligations. FDA personnel note more accurate information from industry because submitted data is more consistent. This improved accuracy is due to step-by-step guidance and a built-in validation against CDER master data, which provides stronger data integrity. Figure 1 illustrates these benefits.

	Industry has welcomed the addition of controlled correspondence to the Portal. In the first two months after its release, 272 company representatives signed up for the new functionality and FDA received 689 controlled correspondence. FDA is receiving about a dozen controlled correspondence daily through the Portal. Those in industry who have used the Portal’s controlled correspondence functionality describe it as more convenient and a better format for submissions compared to the process of sending requests via email. Overall, FDA received more than 2,500 controlled correspondence inquiries in 2018, with 100% of them email until October and then 99% via the Portal since October. Since its launch in late 2018, use of the Portal has quickly grown.

	With the addition of the Portal, industry submissions are more consistent and simpler to acknowledge and triage, and controlled correspondence are easier to track. In just a few steps, industry initiates and submits controlled correspondence to a convenient online location. In short, the Portal provides a win-win solution for FDA and industry and opens opportunities to further improve the regulatory communication process.

, Office of Generic Drugs, Office of Regulatory Operations; 

, Office of Business Informatics, Division of Regulatory Review and Drug Safety Services and Solutions.

	Additional contributors of this article include: Shannon Hill, Christina Marshall, Marissa McNall, and Kelly Miller.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM583436.pdf

	3. More information online at FDA.gov here: 

https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm411122.htm

Articles

As part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
