FDA Announces the Availability of Guidance for Industry: Questions and Answers on Quality-Related Controlled Correspondence Today, the Food and Drug Administration is announcing the availability of guidance for industry entitled, "Questions and Answers on Quality-Related Controlled Correspondence." The Office of Pharmaceutical Quality (OPQ), within FDA's Center for Drug Evaluation and Research, reviews correspondence from generic drug manufacturers, their representatives, and others in the industry related to generic drug development (i.e., controlled correspondence submissions) requesting information regarding chemistry, manufacturing, and controls, as well as product quality microbiology for generic drugs. OPQ also reviews controlled correspondence inquiries related to Type II drug master files for drug substances submitted in support of generic drug applications. The questions and answers published today are intended to proactively respond to those scientific and regulatory topics that appear frequently in controlled correspondence addressed by OPQ, thereby allowing industry to move forward with certain generic drug development activities without the need to submit controlled correspondence to FDA. FDA recommends industry review these Q&A before submitting a controlled correspondence for one of the scientific and regulatory topics captured in the guidance. The agency will add Q&As periodically to this guidance. We intend to use this format to provide timely answers to questions about generic drug development related to quality. For additional information, see FDA's guidance for industry "Controlled Correspondence Related to Generic Drug Development" (December 2020). These Q&A clarify existing requirements or policy and are considered Level 2 guidance. You may submit comments on this guidance at any time via www.regulations.gov to Docket No. FDA-2017-D-6821. | 
No comments:
Post a Comment