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11 October 2018Americas

FDA issues guidance on generic versions of complex drugs

The US Food and Drug Administration (FDA) has released guidance intended to advance the development of generic versions of complex medical drugs.

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More on this story

Big Pharma
FDA to focus on data in new ‘top strategic priority’
7 December 2018   The US Food and Drug Administration has announced a new strategy for the use of “real-world evidence” and “real-world data” to improve its regulation of new drugs.
Biotechnology
FDA releases plan to boost biosimilars development
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Medtech
FDA unveils plans to boost innovation of medical devices
19 December 2018   The US Food and Drug Administration has announced a new programme to boost the innovation of safer medical devices and breakthrough technologies.

More on this story

Big Pharma
FDA to focus on data in new ‘top strategic priority’
7 December 2018   The US Food and Drug Administration has announced a new strategy for the use of “real-world evidence” and “real-world data” to improve its regulation of new drugs.
Biotechnology
FDA releases plan to boost biosimilars development
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Medtech
FDA unveils plans to boost innovation of medical devices
19 December 2018   The US Food and Drug Administration has announced a new programme to boost the innovation of safer medical devices and breakthrough technologies.

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