Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet." This draft guidance addresses FDA's recommendations regarding clinical trials for drugs being developed for the treatment of celiac disease as an adjunct to a gluten-free diet in adults.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.