Electrical Safety and Performance Considerations 23 March 2021 One of the key tools in combatting the COVID-19 pandemic will be vaccines. They join flu shots, childhood immunizations, and vaccinations for some international travel in a growing list of medical vaccines, many of which need to be stored at certain temperatures. The temperature control requirements for […]
Understanding a product’s classification for regulatory compliance The distinction between product classes can be unclear and/or ambiguous, sometimes requiring interpretation and input from competent authorities. A product can have similar characteristics with other products but may be governed by different regulatory frameworks. When products straddle between two or more regulatory definitions, the European Commission (EC) […]
Using LBA, LC-MS and HRAMS Assay Formats Biomarker validation is a valuable tool in drug development support. Whether through discovery, analytical validation or clinical validation, these tests can be used for diagnosis, monitoring, prediction, response measurement, prognosis, safety or risk assessment. As the routine application of biomarkers in the drug discovery process has grown, it […]
FDA Expectations Regarding Immunogenicity Testing Starting with insulin development in the 1920s, therapeutic proteins have evolved quickly in modern medicine. Most of these biologics elicit a specific immune response, Anti-Drug Antibodies (ADA), that are clinically benign. However, some individuals can be adversely affected. For this reason, therapeutic protein products must undergo immunogenicity testing using assays […]
Medical Device Approvals with the National Medical Products Administration (NMPA) In China, medical device manufacturers must have products approved by the National Medical Products Administration (NMPA), the equivalent of the FDA in the U.S. The process can be complex, expensive, and often frustrating at times. Until now. There are three steps for medical device attestation […]
Why the alignment of audit scope with the correct industry standard is important Pharmaceutical supply chains are typically vast and complex, often covering multiple geographical regions and involving a diverse set of suppliers, service providers and subcontractors. To maintain a constant focus on quality across the supply chain network, it is common practice for a […]