ICER’s Unsupported Drug Price Increase Report: An Analysis
We analyze the drug-price watchdog, ICER’s (Institute for Clinical and Economic Review) “Report on Unsupported Price Increases.”
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Health Canada PRCI Guiding Principles and Observations
Health Canada released guidance on 3월 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to … Continued
FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts
Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued
Trends for Market Access, HEOR, and Real World Evidence
This blog reviews trends for using health economics and outcomes research and real-world evidence to evaluate the value of medicines and health technologies.
Real World Evidence Marches Forward in Drug Development
The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not new, they are now poised to have a profound impact on our industry. Today, it … Continued
Managing Immunogenicity Using Quantitative Systems Pharmacology
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and … Continued
7 Things to Know About the China Pharmaceutical Industry
China is the second largest pharmaceutical market in the world. Demand is likely to increase as the government introduces reforms to improve the country’s health care system. These changes are helping multinational drug makers tap into the Chinese pharmaceutical market. Synchrogenix’s China Service Line has compiled a list of seven things to know about the … Continued
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of computer readable datasets. SEND is one of the required standards for data submission to the U.S. Food and Drug Administration (FDA) and specifies a way to collect and present nonclinical data in a consistent format. The … Continued
FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to … Continued
Clinical Pharmacology Gap Analysis: Lessons Learned
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. … Continued
