FDA issues: Final Guidelines for written consultation of generic manufacturers to address concerns of enterprises

Source: HPC Medicine News / Mandy compilation 2015-10-14 background: the draft guide was released in August 2014, which is the fourth guidance document under the generic drug user fee Act (gdufa) in 2012 It aims to answer the questions that enterprises submit to FDA before generic drug review The formal questions raised shall clarify the questions that will affect the drug review The guidelines provide additional details and suggestions for enterprises: • what kind of consultation FDA considers to be a written consultation in line with its gdufa commitment? What kind of information can be included in the written consultation? What kind of information FDA will provide to "controlled response" when communicating with the written consultant, That is to say, the definition of "written consultation" in this paper covers a series of issues that may affect generic drug manufacturers and related industries (for example, CRO, API manufacturer and excipient manufacturer conducting biological analysis or bioequivalence (be) clinical trials) Minor changes to the draft: the draft guide contains revisions to explanatory information that will help generic manufacturers submit written consultation to FDA The final guidance added a description of "how to submit information to FDA's inactive ingredient database" and enhanced communication with applicants based on the status of written consultation Exception: FDA points out three consultation methods in the final guidance, all of which belong to the scope of written consultation, but FDA still believes that these three consultation methods are different from other generic consultation methods It includes: (1) applying for advice on be research and design of specific drugs; (2) applying for review of be clinical scheme; (3) discussing generic drug development in the application meeting before the submission of Anda, FDA said that these consultations are not included in the target time of gdufa commitment letter In this letter of commitment, FDA's response time to written consultation will gradually accelerate: • in fiscal 2015, 70% of consultation will receive FDA's response within 4 months from the date of submission • in fiscal 2016, 70% of the consultations received FDA responses within 2 months from the date of submission • in fy17, 90% of the consultations received FDA responses within 2 months from the submission date Industry comment: in its comments on the draft, the Generic Pharmaceutical Association (gpha) objected to these exceptions, saying that they "are unacceptable and do not meet the required gdufa commitments." In addition, gpha raised objections to the guidance's recommendation to terminate communication with applicants on issues considered complex in the study "This proposal goes against the basis of gdufa: to strengthen FDA's scientific knowledge base, improve communication, and increase transparency," gpha said "Gpha invites the FDA to establish a system to ensure timely responses to written inquiries, including those with complex issues." FDA response: although it did not directly answer gpha's questions about exceptions, FDA noted that it had received multiple comments asking it not to exclude the bioequivalence guidelines for specific drugs FDA said that "the rapid response of written consultation is inconsistent with the" complete process of providing advice for special drugs "in the June 2010 bioequivalence Research Guide for special drugs and the principle of gdufa commitment letter." The FDA also said it had received comments on how it "responded to questions that had no relevant policy." "For these comments, FDA is revising its recommendations If there is a better mechanism than written consultation for applicants to obtain consultation from FDA, FDA will inform applicants, such as pre anda meeting application or regulatory science initiative."