One of the key lessons we learned in addressing biowaiver requests for non-RLD strengths until 2022 was a fundamental misinterpretation of FDA’s 5% allowance for rate-controlling polymers (RCPs). Initially, we assumed that as long as the total amount of RCPs remained unchanged, we could increase one polymer by 5% and simultaneously decrease another polymer by…
21 CFR Part 11 is the FDA regulation for electronic records and electronic signatures. It establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. Key Requirements of 21 CFR Part 11 Electronic Records Electronic Signatures System Validation Security Controls Who Needs to Comply?…
Authoring a high-quality CMC (Chemistry, Manufacturing & Controls) dossier is crucial for regulatory approval. However, many submissions face delays due to avoidable mistakes. Here are some common pitfalls and how to avoid them: Inconsistent Data Across Sections Lack of Justification for Critical Parameters Poorly Structured or Redundant Content Incomplete Stability Data Failure to Address Regional…
The role of regulatory affairs professionals in the pharmaceutical industry is to ensure compliance with regulatory requirements and guidelines set by various regulatory authorities. ​ They play a crucial role in the development, approval, and post-marketing surveillance of pharmaceutical products. ​ Some specific responsibilities of regulatory affairs professionals include: ​ Regulatory Strategy Development They are…
The purpose of regulatory submission and review is to obtain approval from regulatory authorities for the marketing and sale of pharmaceutical products. ​ Regulatory submission refers to the process of preparing and submitting comprehensive documentation to regulatory authorities that provides evidence of the safety, efficacy, and quality of the product. ​ The regulatory review process…
Fixed-dose combination (FDC) drug products present unique challenges in biowaiver assessments, as they involve multiple active pharmaceutical ingredients (APIs) with different physicochemical properties and release characteristics. Regulatory guidelines (USFDA, EMA, WHO) provide biowaiver provisions, but their applicability depends on several factors, such as API solubility, permeability, formulation type, and release mechanisms. Key Considerations for Biowaivers…
