Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming ...

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In this chapter, we gather together and present the board’s recommendations on three types of international comparative education studies, categorized according to their initial, primary purpose: Type ...

Correspondence to Dr Parco M Siu, The University of Hong Kong, Hong Kong, 999077, Hong Kong; pmsiu{at}hku.hk Data sources Embase, MEDLINE, PsycINFO, Cochrane Library, Web of Science, Scopus and ...

Drugs like semaglutide, the active ingredient of Ozempic and Wegovy, are more effective in treating type 2 diabetes than conventional treatments, a comprehensive new comparative study finds. About one ...

The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

The European Medicines Agency (EMA) has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative ...