by Prakash Achaary | Dec 13, 2023 | News
Canton, Mich. (December 13, 2023) – MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with...
by Prakash Achaary | Dec 5, 2023 | Blog
From a drug development perspective, benefit-risk assessments can sometimes feel abstract. However, from a patient’s perspective, they are a lived experience with a disease state and therapy. One benefit-risk assessment exists in paper and data, while the other...
by Prakash Achaary | Nov 30, 2023 | Blog
Good Laboratory Practice (GLP) is a quality control system for clinical research laboratories and organizations to ensure the integrity, consistency, and reproducibility of the data within non-clinical and clinical studies of products in development for human or...
by Prakash Achaary | Nov 28, 2023 | Blog
The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...
by Prakash Achaary | Nov 23, 2023 | Blog
Standard Operating Procedures (SOPs) in the pharmaceutical industry are documents used by an organization to provide step-by-step actions for a specific process. And, according to a published study in ResearchGate, a typical pharmaceutical company must manage an...