The CDISC Standard for the Exchange of Nonclinical Data (SEND) requirements for US Investigation New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) requirements, designed to improve the ease of nonclinical data review...

aTyr Pharma, Inc. was recently granted orphan drug designation by the European Commission (EC) for Efzofitimod for the treatment of sarcoidosis. Sarcoidosis is characterized by the accumulation of immune cells that form granuloma, which typically begins in the lungs,...

In the US, a rare disease is defined as one that affects less than 200,000 people. While these specific diseases are considered rare, living with a rare disease is not. In the US alone, over 30 million people are living with 7,000 different types of rare diseases.1 A...

The FDA recently proposed to replace its current annual reporting requirements for Investigational New Drug (IND) applications with Development Safety Update Reports (DSURs). What Does the FDA’s Proposed Change Mean? Under 21 CFR 312.33, FDA requires Sponsors with an...

Project Renewal is an initiative established by the FDA to reassess outdated oncology drug products and modernize them. The Oncology Center of Excellence (OCE) recently approved a labeling update for Genentech’s capecitabine tablet, known as Xeloda. In this labeling...

New recommendations for IRB review, informed consent and expanded access policies. FDA recently announced the availability of a revised draft Guidance for industry on expanded access (EA) to investigational new drugs (INDs) for treatment use, which consists of...

Regulatory Information Management Systems Software (RIMS) are centralized platforms designed to support and streamline Regulatory Affairs teams and operations. RIMS helps in the creation, organization, submission, and archival of regulatory information in regulated...