Center
for Drug Evaluation &
Research (CDER) News |
Center
for Biologics Evaluation & Research (CBER) |
Center
for Device &
Radiological
Health (CDRH) |
Federal Register -
Meetings, Notices, & Rule Changes |
CDER Drug Links
|
CBER Links
|
Medical Device Links
|
Weekly
Rule Changes
NONE |
|
Friday,
August 01, 2008 |
|
NOTICES
Medical
Device User Fee Rates (2009
FY),
4501445017 [E817739]
[TEXT] [PDF]
Prescription Drug User Fee
Rates (2009 FY),
4501745022 [E817738]
[TEXT] [PDF]
|
|
Thursday,
July 31, 2008 |
|
NOTICES
Agency
Information Collection
Activities; Proposals,
Submissions, and Approvals,
4474844749 [E817566]
[TEXT] [PDF]
44749 [E817576]
[TEXT] [PDF]
4474944751 [E817577]
[TEXT] [PDF]
|
|
Wed.,
July 30, 2008 |
|
NOTICES
Draft Guidance for
Industry: Nucleic Acid
Testing to Reduce the:
Possible Risk of
Parvovirus B19 Transmission
by Plasma-Derived Products;
Availability,
4427244273 [E817431]
[TEXT] [PDF]
|
|
Tuesday,
July 29, 2008 |
|
NOTICES
Amendments Act (of
2007):
Prohibition Against Food to
Which Drugs or Biological
Products Have Been Added,
etc.,
4393743940 [E817356]
[TEXT] [PDF]
Determination:
SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not
Withdrawn From Sale for
Reasons of Safety or
Effectiveness; Correction,
43940 [E817303]
[TEXT] [PDF]
Draft Information Sheet
Guidance,
4394043941 [E817305]
[TEXT] [PDF]
Meetings:
Blood Products Advisory Committee,
4394143942 [E817359]
[TEXT] [PDF]
Risk Communication Advisory
Committee,
4394243943 [E817304]
[TEXT] [PDF]
|
|
Monday,
July 28, 2008 |
|
NONE
|
|
|
|
EU - US - ICH GMP
Combination Product
handbook |
|
US GMP Training Booklet |
|
Std. GMPs
- Parts 11, 210, 211, 820 &
ICH Q7 |
|
Med. Device - 11, 50,
54, 56, 807, 812, 814, 820,
510k/PMA |
|
Clinical GCP - Parts 11,
50, 54, 56, 312, 314 & ICH
E2A & E6 |
|
Multi-US GMPs 11, 58,
210/211, 600, 601, 610
& 820 |
|
Parts 210/211 - Drug
GMPs |
|
>210/211
with Part 11 |
|
>210/211
with Part 820 |
|
>210/211
with Parts 820 & 11 |
|
>210/211
w/ Keyword Index |
Part 820
Quality Systems Regs
|
|
Part 58 - GLP Good
Lab. Practice |
Part 11
- Electronic Records w/
Scope and Applications
|
GLP 2 11 & 58 - Part 11
& 58
|
PDMA 11,
203 & 205 - Prescription
Drug Marketing
|
|
|
11
& 820 Electronic Record
and Quality Systems
|
|
|
|
The e-Newsletter of
What's New with CDER, CDRH & CBER
Distributed by the worlds
leader in Federal Regulations,
GMP Publications, Inc. & FDA.COM
Tel: 866-GXPNews (or 856-810-7331) Fax: 856-810-7339
http://www.gmppublications.com /
http://www.fda.com
John Cuspilich, Sr. Editor, GXPNews
If you would
like to advertise in this eNewsletter, call
856-810-1825
|
