By; Bob Iser, Vice President, PAREXEL Consulting, Felicia Bullock, Director, PAREXEL Consulting; and Don Klein, Principal Consultant, PAREXEL Consulting
The FDA recently published draft guidance for industry (January 2018) which includes a very helpful “list” of commonly seen deficiencies in ANDA submissions. This “list” includes common concerns from each of the Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ) disciplines (e.g., patent and exclusivity, bioequivalence, microbiology, labeling, etc.). The new draft can be found at the following weblink: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM591134.pdf
This guidance is an important piece of the ongoing GDUFA II implementation and as noted in the guidance “highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.” The guidance further notes that it “does not include a comprehensive list of all of the deficiencies identified during the ANDA assessment”, and “it is each applicant’s responsibility to submit a high-quality, complete application that the FDA can approve in the first review cycle.”
Important CMC topics that are highlighted are as follows: choosing appropriate starting materials for active pharmaceutical ingredients (API); characterizing and controlling impurities in the API and drug products; justifying excipients that are being used in the formulation; setting appropriate drug product specifications (including dissolution); demonstrating the aseptic process is adequately controlled; and providing assurance that the proposed manufacturing process will yield consistent commercial product.
Companies that are currently developing or planning to develop generic products for the U.S. market should seriously consider this information so the approval is not in jeopardy, business plans are not derailed, and products can reach their intended patients.
PAREXEL Consulting’s team of subject-matter experts can provide key advice to companies developing generic products, and preparing ANDA submissions, to avoid review and approval delays, including ensuring an ANDA submission adheres to FDA regulation, guidance and quality expectations.