On Monday, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research issued guidance on commonly asked questions for generic drug applicants, according to the Regulatory Affairs Professionals Society (RAPS).
The FDA’s new guidance, which is in Q&A format, is designed to provide immediate answers to questions covering the drug quality area.
The guidance covers FDA’s policies on quality-related scientific and regulatory topics that “appear frequently” in controlled correspondence submissions CDER’s Office of Pharmaceutical Quality, according to RAPS.
It will help the industry “to move forward with certain generic drug development activities without the need to submit controlled correspondence to FDA,” according to Monday’s announcement that was made via email.
The guidance contains nine Q&As, which are “derived from numerous controlled correspondence submissions.” The topics include:
- bracketing and matrixing
- container closure changes
- dissolution
- endotoxin testing
- number of exhibit batches
- scoring and split tablet testing
The FDA has clarified that it accepts a bracketing approach for a generic drug with multiple strengths, as long as the active and inactive ingredients are as same as its branded counterpart.
The guidance also specifies that generic drug applicants should produce three separate intermediate bulk batches. One batch should represent all the proposed strengths, another should reflect the lowest strength, and the other should reflect the highest strength.
For more information on the new FDA Q&A guidance, applicants should consult FDA’s May 2014 guidance entitled “ANDAs: Stability Testing of Drug Substances and Products Questions and Answers.”
The agency has advised applicants to review these questions before submitting a controlled correspondence on these topics, according to RAPS. The FDA said it will add more Q&As as needed to address more frequently asked questions that may arise in the near future.
