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FDA Publishes Draft Guidance on Controlled Correspondence

On August 27, 2014, the U.S. Food and Drug Administration (FDA) published “Controlled Correspondence Related to Generic Drug Development,” a draft guidance detailing what FDA considers to be a controlled correspondence and the proper way to submit a controlled correspondence.

In a Generic Drug User Fee Amendments of 2012 (GDUFA) commitment letter, FDA agreed to the following performance goals for responding to controlled correspondence submissions:

  • FDA will respond to 70 percent of controlled correspondence in 4 months from date of submission in fiscal year (FY) 2015.
  • FDA will respond to 70 percent of controlled correspondence in 2 months from date of submission in FY 2016.
  • FDA will respond to 90 percent of controlled correspondence in 2 months from date of submission in FY 2017.

If a controlled correspondence requires input from the agency’s clinical division, FDA will add one month to the goal deadline. If the issue raised in a controlled correspondence is the same issue or is related to an issue raised in a pending citizen petition, petition for reconsideration, or request for a stay, the time period for FDA’s response to the controlled correspondence will begin after FDA has responded to the petition or stay request. These goals become effective October 1, 2014.

What Is Controlled Correspondence?

In the draft guidance, FDA defines “controlled correspondence” for the purposes of GDUFA as “a correspondence submitted to the Agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development.” The guidance notes three types of inquiries which meet the controlled correspondence definition that FDA does not hold to the same response time goals as others: bioequivalence guidance requests, clinical protocol requests, and pre-ANDA meeting requests.

The guidance also describes questions that FDA does not consider to be controlled correspondence:

  • Questions about a pending ANDA;
  • Inquiries not directly related to generic drug development;
  • General, broad, and open-ended questions (Questions asked in controlled correspondence submissions must pinpoint a specific element of development); and
  • Questions from entities not directly involved with the development of generic drugs. Controlled correspondence only applies to generic drug manufacturers, related industry, and their representatives.

Submitting Controlled Correspondence

Controlled correspondence should be submitted by email to [email protected]. FDA plans to provide notification via e-mail of the status of a request soon after it is submitted. FDA suggests using a corporate e-mail address, because the agency does not plan to consider submissions from general, personal accounts as controlled correspondence. If FDA determines there is insufficient information to consider an inquiry, the agency may contact the submitter for more information, but they may close the controlled correspondence. FDA will also close a controlled correspondence if the issue at hand is still under FDA consideration.

In the guidance, FDA suggests including the following things in a controlled correspondence submission:

  • The name, title, address, phone number, and entity of submitter;
  • A concise statement of the inquiry for which the controlled correspondence is being submitted;
  • A recommendation of the appropriate review discipline to review the controlled correspondence;
  • Relevant prior research and supporting materials;
  • The FDA-assigned control number and submission date of any previous, related controlled correspondence and a copy of the previous submission and FDA’s response (If applicable);
  • Relevant U.S.-approved reference listed drugs , including application number, proprietary (brand) name, manufacturer, active ingredient, dosage form, and strength(s) (If applicable); and
  • An e-mail address to which FDA can respond.

FDA will only respond to the U.S. Agent or representative of a foreign company. Registrar Corp, an FDA compliance firm, can act as an experienced and reliable U.S. Agent for drug companies and assist with  FDA’s registration, listing, and labeling requirements.

For questions about controlled correspondence or other FDA drug regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.