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Gain a comprehensive view of EU regulatory affairs for pharmaceuticals and biologics during this two-day workshop. Essential regulations, directives, and guidelines affecting Europe's regulatory system will be covered, with specific focus on development considerations, clinical trials, marketing authorization applications, post-marketing requirements, and life-cycle management.
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When developing a regional African regulatory strategy, it is very
important to make an early determination of the key markets that will be
targeted based on the size of country vs. medical need, time to
approval, competition, language, etc. This article addresses East and
Southern Africa, as they are major markets that often follow European
A new guidance document issued by the US Food and Drug Administration (FDA) is trying to clarify the differences between tissue products and procedures which fall under the agency's regulations, and those products and procedures which do not.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Current information on the China Food and Drug Administration regulatory authorities and its inspection systems, including the role of Provincial and City FDAs.
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The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products. View More
On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value. View More
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal. View More
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. View More