This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices. Its seven chapters are divided into three parts. Part I ...

Show the world that you have the foundational knowledge regulatory affairs professionals need. The new Foundation in Regulatory Affairs (FRA) assessment-based certificate is designed to help you build ...

Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, FDA ...

BRUSSELS @ European Commission officials say they have proposed legislative changes to the European Parliament that they hope will ease regulatory requirements for sponsors of combined studies based ...

The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for existing drug and biologics dossiers to the common technical document ...

ROTTERDAM, NETHERLANDS @ A panel of experts at RAPS@ European Digital Technology and Software Conference on Thursday urged regulatory professionals to embrace artificial intelligence (AI). They said ...

This conference explores the evolving regulatory landscape for advertising and promotion of biopharmaceuticals and medical devices, with a focus on innovation, compliance, and patient-centric ...

BSI’s UK notified body announced Wednesday that the Novartis Concept1 inhaler is the first device to be certified under the new EU Medical Devices Regulation (MDR). While previously classified as a ...

The International Council for Harmonisation (ICH) has endorsed the eCTD @ the electronic common technical document @ as the message standard for electronic submissions. This article presents an ...

The Drug Regulatory Authority of Pakistan (DRAP) has published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally manufactured biological ...

This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.