CVM develops and issues its guidance documents in accordance with FDA's good guidance practices regulations (21 CFR 10.115) published in the Federal Register on September 19, 2000 (65 FR 5646).
Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach can be used if the approach satisfies the requirements of the applicable statutes and regulations.
Some CVM guidance documents on this list are indicated as DRAFT. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that CVM considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through regulations.gov. For more information, see:
When a guidance document is finalized, it replaces the draft version posted on the list below.
GUIDANCE BY SUBJECT