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GUIDANCE DOCUMENT

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry Draft Guidance for Industry December 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
2019-D-4656
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

This guidance provides recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

This guidance incorporates recommendations the FDA received at a December 2017 advisory committee meeting on trial design features, including enrollment criteria and acceptable effectiveness endpoints for drugs intended to treat IC/BPS.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-D-4656.