by Prakash Achaary | Feb 10, 2023 | Blog
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...
by Prakash Achaary | Feb 7, 2023 | News
CANTON, Mich. (2/7/2023) – MMS Holdings (MMS) – an award-winning, data-focused contract research organization (CRO) – announces the expansion of its leadership team with the appointment of Chris Schoonmaker as Chief Operating Officer. This comes as the company was...
by Prakash Achaary | Feb 6, 2023 | Blog
Project Renewal is an initiative established by the FDA to reassess outdated oncology drug products and modernize them.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...
by Prakash Achaary | Feb 2, 2023 | Blog
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 FDA recently announced the availability of a revised draft Guidance for industry on expanded access (EA) to investigational new drugs (INDs) for treatment use, which consists of...
by Prakash Achaary | Jan 25, 2023 | Blog
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...