Listed below are recently added guidance documents regarding oncology and malignant hematology.
Commenting on Guidance Documents
Some FDA guidance documents on this list are indicated as open for comment. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date.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:
About FDA Guidances
Guidance documents represent the Agency's current thinking on a particular subject. 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 may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. Another method of obtaining guidance documents is through the Division of Drug Information.
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