Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...

Whether you're looking for a classic or the latest and greatest, start here. By The New York Times Books Staff Here are the year’s notable fiction, poetry and nonfiction, chosen by the staff ...

Amazon is launching Alexa+, an upgraded version of its AI-powered assistant, designed to be smarter, more conversational, and capable of handling complex tasks like making dinner reservations or ...

“Together with the US FDA orphan designation, the positive opinion from the EMA represents an important step towards this significant regulatory milestone for the company in Europe and positions ...

Bret Erickson, senior vice president of business affairs at Little Bear Produce BB #:124521 ... our industry is struggling under the weight of labor shortages, rising costs, and regulatory burdens ...

These two books present vivid accounts of right-wing movements that seek to undermine the modern regulatory state, or what conspiracists call “the deep state.” Until recently, a capable government ...

Drawing on utilitarian calculations of costs and benefits, the book develops a logic of obligations over space and time: wealthy countries owe much to poorer ones, just as the current generation owes ...

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

The EO gives agencies 60 days to provide the Office of Information and Regulatory Affairs at OMB with a list of regulations that should be either rescinded or modified. Trump is also telling agencies ...