On December 08, 2014 US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” This guidance provides recommendations to sponsors on Continue reading
The Pregnancy and Lactation Labeling Rule, formally known as the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (PLLR) has been published by the FDA.
The PLLR has been put into place in order to assist health care providers in Continue reading
The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.
The new guidance Continue reading
Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.
As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.
This past year, we Continue reading
The US Department of Health and Human Services Department (DHHS) proposed a new rule with respect to Clinical Trial Registration and Results Submission. This proposed rule Continue reading
The world and the African continent in particular are currently experiencing the worst Ebola virus disease (EVD) outbreak in modern history. With more than two thousand deaths estimated due to the Continue reading
A Certificate of a Pharmaceutical Product (CPP) is a certificate used by the Health Products and Food Branch Inspectorate (HPFB Inspectorate) “establishing the status of Continue reading
On April 25, 2014, the EMA released a draft guideline on Process Validation for the Manufacture of Biotechnology-derived Active Substances and Data to be Provided in the Regulatory Submission. This document is intended to provide guidance on Continue reading
On February 19, 2014, the FDA announced its revised draft guidance for industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics”. The 2014 draft guidance will Continue reading
The US Food and Drug Administration (FDA) has released a new draft guidance document regarding the content of pediatric study plans (PSPs) and the process by which industry should submit them to the Continue reading