Generics: The FDA’s Approval Track Record and New Guidance Drafts
The US Food and Drug Administration (US FDA) has set a new milestone for the number of generic drug approvals once again. So far this year, FDA has approved a total of 971 generic drugs, including 781 final approvals and 190 provisional approvals, compared to 937 approvals in FY 2017. In this year’s approvals, complex generic drugs accounted for 12% of all approvals.
The rising number of approvals indicates that generic drugs have a large market in the United States. FDA has issued one updated and a new draft guidance to advance the creation of generic transdermal and topical delivery systems in an effort to get applicants to comply with the rising number of approvals (TDS).
The new and updated drafts, as well as the new guidelines, are listed below:
- Irritation and sensitization are the first two things that come to mind:
ANDA sponsors will use the latest guidelines to design and perform trials to assess the potential for irritation and sensitization (I/S). Applicants should conduct a comparative evaluation of the generic and reference TDS products using an appropriately built skin irritation and sensitization (I/S) sample with human subjects to demonstrate that the potential for a skin irritation and sensitization (I/S) reaction with the T TDS is no worse than the reactions with the R TDS. To optimize the potential for irritation and sensitization (I/S) reaction, both studies should be performed in a reasonably provocative situation with a limited sample of the population, according to the guidance.
The guidance also specifies the terms of study design and conduct evaluation, statistical analysis consideration (i.e., annoyance and sensitization analysis), and overall assessment of event results, as well as the data submission format.
- Adhesion Evaluation:
The new guidance is based on a draught that was published in June 2016. The document contains guidelines for evaluating a TDS’s adhesive strength. It allows the applicant to choose an assessment course based on the TDS product development program’s goals. The following are the two possibilities:
- TDS adhesion was evaluated in clinical trials that were solely based on TDS adhesion.
- TDS adhesion in clinical trials with a dual objective (e.g., for the simultaneous assessment of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints)
The guideline also specifies the guidelines for research/study design and conduct, statistical analysis considerations, combined adhesion and bioequivalence evaluations, and submission format.
The fact that the FDA has approved a greater number of generic drugs demonstrates the agency’s desire to make them more available to the general public. More entrants and, as a result, lower prices could be possible as a result of this. Manufacturers and applicants, on the other hand, would need more scientific and regulatory clarity to keep up with the market. FDA is planning to release an umbrella guidance to provide clarification on certain regulatory and scientific information standards, which will be supplemented by a series of tailored guidance documents to resolve legal issues.
Manufacturers must keep track of future guidance documents as a result of the simplified generic drug review. Consult a Regulatory specialist to decipher them and answer questions about generic drug applications with the FDA.
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