I'm a Psychic...About Timing of Articles Related to Open Comment Periods Related to Psychedelics.

New FDA Guidance is out today!

Yesterday, in my almost-only one-human-penned leading health-parody-regulatory-enthusiast-newsletter, I wrote about potential FDA Issues related to psychedelic drug development and advertising.

And today, as if magic, the FDA has released new Guidance on Psychedelic Drug Development.

And, readers, get excited…it features…

An Open Comment Period!

You can read the draft guidance document here.

The irony is that I edited this picture together featuring myself (left), noted Research Scientist Nolan R. Williams, M.D., and Psychedelic Anonomyous Characters together from other images in which we were together in Brooklyn for real— but were insufficiently “trippy.”

Bangers only might as well be the FDA guidance for FDA Guidance. Questions like these new clinical trials being considered for a medicine from the Plant Gods? Consider if they are made of:

Mplant material, algae, macroscopic fungi, or a combination of these, the investigational product may be considered a botanical, as that term is defined in the guidance for industry Botanical Drug Development (December 2016).

The firey guidance continues…you are not going to believe how off the hook the FDA is willing to be: