No sooner posted, then found. Here is where you can get a PDF and see what it says--
http://www.fda.gov/cber/gdlns/altmed.pdfAt first glance, it doesn't look as bad as advertised, but this IS just a first glance--I haven't yet pored over it carefully. It begins:
Quote:
"This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statues and regulations."
So I gather from this that currently these are guidelines, not laws. So far.
It also gives an address and phone numbers to call for comments, and frankly, I would suggest using these means to comment rather than the website linked here, primarily because that website gathers too much personal information, and who knows what they (or some hacker) will do with it.
