Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Importantly, midomafetamine was proposed for use in conjunction with psychotherapy.

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Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g.,

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FDA Science Regulations Biosimilars 40

Drug Discovery World

FEBRUARY 26, 2024

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

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Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either. A flurry of new, promising therapeutic targets arose.

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Agency IQ

FEBRUARY 15, 2024

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. Priority B List.

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FDA Science Biosimilars Production 40

Drug Discovery World

FEBRUARY 22, 2024

There is now hope that new treatments will arise to overcome the limitations of existing therapies and relieve the millions of patients suffering worldwide 4 ”. The report also highlights that the global neuroscience market (GNM) “was worth $612 billion in 2022 and could grow to $721 billion by 2026.

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Drugs Clinical Trials Disease Therapies 147