Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic…
Read More
CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the…
Read More
An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been…
Read More
To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the…
Read More
There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA): Requests for authorization for clinical investigations Requests for marketing approval…
Read More
It’s never too early to start planning for your NDA Begin assembling your NDA early Understand the relevant statutes and regulatory guidelines that apply to your program Use standardized templates…
Read More
Content updated on August 11, 2021 An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage…
Read More