In January 2020 the Food and Drug Administration (FDA) reviewed its 2017 draft content and published finalized guidance for in vitro and clinical drug interaction studies. We’ve summarized the the key changes and implications for in vitro drug-drug interactions (DDI) testing in this post, but if you would like more …
5 Things to Know About the Evolving Requirements For SEND
As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights …
Accelerating FDA Submissions with the Trial Summary Domain
A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, …
Preclinical Success to Clinical Failure: Do We Have a Model Problem or an Endpoint Problem?
As the AACR (American Association for Cancer Research) Annual Meeting is fast approaching, many industry and academic scientists are busy preparing talks and posters for what they hope will be the next new wave in cancer therapy or the next “new and improved” preclinical model. However, while these may be …
The Biosimilars Landscape: What All Developers Need to Know
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, …
Understanding Regulatory and Market Access Considerations With Drug Abuse Potential
Each assessment for abuse liability is as unique as the molecule in question, reiterating the importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly. In our previous blog post, we focused on the value of early drug abuse potential testing. …