If you were to see the phrase ‘Advanced Therapy Medicinal Product’ (ATMP) you might guess, ‘an advanced treatment that is a medicine?’ but you will not get much more from this without doing a lot more homework. What is an ‘Advanced Therapy Medicinal Product’ (ATMP)? Whoever decided that cell and gene therapy products should be described …
Cell and gene therapy products: what is an ATMP? Read More »
It’s notable how the FDA now considers gene-editing a kind of regenerative medicine. This means that various gene therapy products in development technically qualify as regenerative therapies. Ever since the agency began its rapidly growing regenerative medicine advanced therapy (RMAT) designation program, we’ve seen an increasing number of gene therapy biotechs and products qualify as …
Regenerative medicine recommended reads including $191 million to researcher Read More »
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm …
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
I have a new Cell Stem Cell piece out today that aims to take stock of today’s stem cell regulatory oversight in the U.S., Japan, and elsewhere including Australia, Canada and India. I use a carrot and stick metaphor for encouraging legit research and taking regulatory action on serious non-compliant activities, respectively. Where is stem cell …
My new Cell Stem Cell piece: too much carrot & not enough stick on stem cell oversight Read More »