Products: What are they?
Any product formed
from the combination of a drug, a device and a biologic is referred to as a combination
product. Under 21 CFR 3.2 (e) this
includes two or more regulated components that are physically, chemically, or
otherwise combined or mixed and produced as a single entity.
SEND [Standard for Exchange of Nonclinical Data] is more than just a tool to facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.
Both large pharmaceutical and emerging biotechnology companies face many obstacles and potential pitfalls in the drug development process. From early development stages to commercialization, many coordinated, cross-functional efforts are required to meet key milestones and keep a program on track.
A comprehensive development strategy and plan can provide a detailed roadmap on how to make critical development decisions, improve efficiency, reduce costs and even shorten timelines. By outlining a plan for advancing a program and meeting regulatory, nonclinical, clinical, commercial and CMC requirements, a company is better prepared to proactively mitigate common risks and improve the likelihood of successful regulatory approvals around the world.
Learn more about the essential components of a comprehensive drug development plan, which can provide a basis for sound investment decisions and enable project portfolio prioritization and management.
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Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Abuse Potential, we are sharing how we design and setup accurate and valid nonclinical GLP abuse liability study types required by regulatory agencies: self-administration, drug discrimination and physical dependency.
Below is a short summary of the full-length article (available for download) that explores how to design a drug discrimination study with in-house data samples from Covance. Continue reading
Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China.
As a continued commitment to meet clients’ needs and conform to local Chinese regulations, the Covance Central Laboratory Services Shanghai team (Covance CLS Shanghai) provides guidance to our clients to navigate CFDA inspections. Backed by more than 10 years of experience in China, the Covance CLS Shanghai team delivers a deeper understanding of CFDA regulatory and operational requirements and helps clients with a standardized process and corresponding documentation.
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading