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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

All in all, this is a 10-year period, which the commission seeks to shorten. According to the Wellcome Trust 5 , it can take between 10 and 15 years and over $1billion to develop a new antibiotic, so systems such as this aim to provide incentive to drug developers. You can compare timelines.

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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