Last Updated 3 April, 2009
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CFR Rule Change |
Industries Impacted |
Date of Notification |
Data of last Revision |
Latest Revision Available?
Comments |
|
21 CFR Part
56 |
Clinical
Industry |
January 15,
2009 |
July 14, 2009 |
|
|
21 CFR
Part 101 |
Food
Labeling |
January
5, 2008 |
January 5,
2011 |
Yes -
Updated Handbook Available
Revised
as of May 27, 2008 |
September
29, 2008
May 27, 2008
May 1, 2008 |
January
1, 2010
May 27, 2008
May 1, 2008 |
|
21 CFR
Part 111 |
Dietary Supplements |
May
14, 2008 |
May
14, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 201 |
Food
Industry |
March
26, 2009 |
March
26, 2009 |
|
|
21 CFR
Part 203 |
Drug
Industry |
March
26, 2009 |
March
26, 2009 |
Yes -
Updated Handbook Available |
|
October
9, 2008 |
November
10, 2008 |
|
21 CFR
Part 205 |
Drug
Industry |
October
9, 2008 |
November
10, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 210 |
Drug
Industry |
July
15, 2008 |
September
15, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 210/211 |
Drug
Industry |
September
8, 2008 |
December
8, 2008 |
Yes -
Updated Handbook Available
Included
in all 210/211 combinations |
|
21 CFR
Part 310 |
Clinical
Industry |
March
26, 2009 |
March
26, 2009 |
|
|
March
6, 2009 |
March
6, 2009 |
|
21 CFR
Part 312 |
Clinical
Industry |
March
26, 2009 |
March
26, 2009 |
Yes -
Updated Handbook Available |
July 10,
2008
April
28, 2008 |
August 11, 2008
October
27, 2008 |
|
21 CFR
Part 314 |
Clinical
Industry |
March
26, 2009 |
March
26, 2009 |
Yes -
Updated Handbook Available
Changes
posted September
29, 2008 to be effective February 11, 2009 were
Withdrawn Feb. 10, 2009 |
|
March 6, 2009
August 22, 2008
July 10, 2008 |
March 6, 2009
September
22, 2008
August 11, 2008 |
|
21 CFR
Part 600 |
Biologic
Industry |
March
26, 2009 |
March
26, 2009 |
Yes -
Updated Handbook Available |
|
July
10, 2008 |
August
11, 2008 |
|
21 CFR
Part 601 |
Biologic
Industry |
November
18, 2008 |
November
18, 2008 |
Yes -
Updated Handbook Available |
August
22, 2008
July 10, 2008 |
September
22, 2008
August 11, 2008 |
|
21 CFR
Part 610 |
Biologic
Industry |
September
19, 2008 |
September
19, 2008 |
Yes -
Updated Handbook Available |
|
August
25, 2008 |
August
25, 2008 |
|
21 CFR
Part 640 |
Biologic
Industry |
September
19, 2008 |
September
19, 2008 |
Yes -
Updated Handbook Available |
|
August
25, 2008 |
August
25, 2008 |
|
21 CFR Part
700 |
Cosmetic
Industry |
April
17, 2008 |
July
16, 2008 |
Yes -
Updated Handbook Available
included
in all cosmetic combinations |
|
21 CFR
Part 800 |
Device
Industry |
June
19, 2008 |
June
19, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 801 |
Device
Industry |
June
19, 2008 |
June
19, 2008 |
Yes -
Updated Handbook Available |
|
June
2, 2008 |
October
15, 2008 |
|
21 CFR
Part 803 |
Device
Industry |
June
13, 2008 |
October
27, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 808 |
Device
Industry |
June
19, 2008 |
June
19, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 812 |
Device
Industry |
September
19, 2008 |
September
19, 2008 |
Yes -
Updated Handbook Available |
|
August
25, 2008 |
August
25, 2008 |
|
21 CFR
Part 814 |
Device
Industry |
March 31,
2009 |
March 31,
2009 |
Yes -
Updated Handbook Available |
September
19, 2008
August
25, 2008
August 22, 2008
June 19, 2008 |
September
19, 2008
August
25, 2008
September 22, 2008
June
19, 2008 |
|
21 CFR
Part 821 |
Device
Industry |
June
19, 2008 |
June
19, 2008 |
Yes -
Updated Handbook Available |
|
21 CFR
Part 822 |
Device
Industry |
September
19, 2008 |
September
19, 2008 |
Yes -
Updated Handbook Available |
|
August
25, 2008 |
August
25, 2008 |
|
21 CFR
Part 860 |
Device
Industry |
September
19, 2008 |
September
19, 2008 |
Yes -
Updated Handbook Available |
|
August
25, 2008
June 27, 2008
June
19, 2008 |
August
25, 2008
June 27, 2008
June
19, 2008 |
|
ICH |
|
ICH E2 |
Clinical
Industry |
New
Codification - November 2005 |
Current Step
4 version dated 27 October 1994 |
|
|
ICH E6 |
Clinical
Industry |
New
Codification - November 2005 |
Current Step
4 version dated 10 June 1996 |
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