Clinical Research, Pharmacokinetics, Regulations and Workshop

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

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. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA

FDA Trials Regulations Therapies

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. FDORA also directed the FDA to convene a meeting.

FDA

FDA Research Clinical Trials Regulations

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

See AgencyIQs analysis of a workshop on novel methodology qualification.] The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. novel methodology qualification.

Clinical Trials

Clinical Trials Trials Treatment Production

Drug Discovery Digest

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

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