An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
The guidance outlines key issues for determining the reliability and relevance of the data and that should be addressed in the study protocol, including: the appropriateness and potential limitations ...
Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...
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