
Mark A. Tobolowsky
Articles
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3 weeks ago |
saludequitativa.blogspot.com | Mark A. Tobolowsky |Ricardo Carvajal
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3 weeks ago |
thefdalawblog.com | Ricardo Carvajal |Mark A. Tobolowsky
Among other things, EO 14212 established the Make America Healthy Again (MAHA) Commission (with HHS Secretary Kennedy as its Chair) and tasked it with a tall order: submission to the President of an Assessment that tackled 10(!) complex public health issues within 100(!) days. Perhaps it was inevitable that the Commission would turn to AI for help, as seems to have been the case in light of media reports that the Assessment as originally published included references that don’t exist.
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Feb 4, 2025 |
mondaq.com | Mark A. Tobolowsky |Charles Raver |James Valentine
We recently blogged about a new December 2024 draftguidance about accelerated approval (the "December 2024 draftguidance"). That post largely focused on endpoints as well asthe broader context for when accelerated approval is appropriate. However, as we note in that post, the design, timing of initiation,and timely conduct of confirmatory trials are also importantconsiderations in FDA's determination of whether acceleratedapproval is appropriate.
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Dec 9, 2024 |
mondaq.com | Mark A. Tobolowsky |Charles Raver |James Valentine |Cheese Consumers
On November 19, 2024, FDA released a draft guidance titled "Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products." As much of the content of this draft guidance for cellular and gene therapy ("CGT") products is articulated elsewhere, this document serves as a one-stop shop or "Cliffs Notes" for the numerous guidance documents now covering CGT product development.
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Dec 6, 2024 |
thefdalawblog.com | Charles Raver |James Valentine |Mark A. Tobolowsky
On November 19, 2024, FDA released a draft guidance titled “Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products.” As much of the content of this draft guidance for cellular and gene therapy (“CGT”) products is articulated elsewhere, this document serves as a one-stop shop or “Cliffs Notes” for the numerous guidance documents now covering CGT product development.
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