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USFDA Guidance: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
Immunogenicity is an important consideration in the development and regulatory evaluation of many biological products and therapeutic proteins. The formation of anti-drug antibodies (ADAs) can influence a drug's pharmacokinetic profile, potentially affecting drug exposure, efficacy, and safety. To support consistent regulatory assessment, the FDA issued the guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug.
Sharan Murugan
Jun 223 min read
Ireland's HPRA Requirements for National Marketing Authorisation Applications and Decentralised Procedures
Obtaining marketing authorisation for medicinal products in Ireland requires careful planning and early engagement with the Health Products Regulatory Authority (HPRA). To support efficient assessment and resource management, the HPRA has established guidance for companies seeking to submit new national marketing authorisation applications and for applicants requesting Ireland to act as the Reference Member State (RMS) in a Decentralised Procedure (DCP). The guidance document
Sharan Murugan
Jun 173 min read
Health Canada draft Guidance: Decentralized Clinical Trials
As clinical research continues to evolve, decentralized clinical trials (DCTs) are becoming increasingly important. By incorporating technologies such as telemedicine, remote monitoring, electronic consent, and home healthcare services, decentralized trials can reduce participant burden and improve access to research opportunities. Recognizing this shift, Health Canada launched a consultation on its Draft Guidance for Decentralized Clinical Trials (DCTs). Feedback from indust
Sharan Murugan
Jun 173 min read