In just a few days, May 5, 2017, the FDA will only accept eCTD formatted submissions for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs). Passing this milestone Continue reading
On December 08, 2014, US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.”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 how to Continue reading
The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has 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
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
On October 08, 2014, the FDA issued a draft guidance for industry entitled “Critical Path Innovation Meetings.” The Critical Path Innovation Meetings (CPIM) provides an opportunity for FDA’s Center for Drug Evaluation and Research (CDER) to discuss Continue reading
The US FDA has released a final guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices to strengthen the safety of medical devices.
Although medical devices have the ability to improve patient care and create efficiencies in the healthcare system as they become more interconnected and interoperable, risks for Continue reading
FDA has released two draft guidance documents on refuse to receive ANDA submissions. The purpose of the guidances are to help applicants prepare “ANDAs and PASs to ANDAs for which the applicant is seeking Continue reading