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Regulations last checked for updates: May 23, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 4
Subpart B - Subpart B—Postmarketing Safety Reporting for Combination Products
§ 4.100 - What is the scope of this subpart?
§ 4.101 - How does the FDA define key terms and phrases in this subpart?
§ 4.102 - What reports must you submit to FDA for your combination product or constituent part?
§ 4.103 - What information must you share with other constituent part applicants for the combination product?
§ 4.104 - How and where must you submit postmarketing safety reports for your combination product or constituent part?
§ 4.105 - What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
360
,
360
b-360f,
360
h-360j,
360
l,
360
hh-360ss,
360
aaa-360bbb,
371
,
372
,
379e
,
381
,
383
,
394
;
42 U.S.C. 216
,
262
,
263a
,
264
,
271
source:
78 FR 4321, Jan. 22, 2013, unless otherwise noted.
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