Center
for Drug Evaluation &
Research (CDER) News |
(CBER) Center
for Biologics Evaluation & Research |
Center
for Device & Radiological
Health (CDRH) |
Federal Register -
Meetings, Notices, & Rule Changes |
|
CDER Links |
CBER Links |
CDRH Links |
July 27, 2007
- FDA permits
restricted use of Zelnorm (tegaserod
maleate) for qualifying
patients.
FDA News
-
New and Generic
Drug Approvals
-
Actonel
(risedronate sodium)
Tablets, Procter & Gamble
Pharma, Labeling Revision
-
BARACLUDE
(entecavir) Tablets,
Bristol-Myers Squibb,
Labeling Revision
-
BARACLUDE
(entecavir) Oral Solution,
Bristol-Myers Squibb,
Labeling Revision
-
Benzonatate
Capsules, ThePharmaNetwork,
Approval
-
Cephalexin
Oral Suspension, Yung Shin
Pharma, Approval
-
Dantrolene
Sodium Injection, US
WorldMeds, Approval
-
Delatestryl
(testosterone enanthate)
Injection, Indevus Inc.,
Labeling Revision
-
EstroGel
(estradiol) Gel, Ascend
Therapeutics, Labeling
Revision
-
Gabapentin
Capsules, Interpharm Inc.,
Approval
-
HELIDAC
Therapy, Prometheus Labs,
Labeling Revision
-
Lamisil AT
(terbinafine hydrochloride)
Cream, Novartis, Labeling
Revision
-
Paroxetine
Tablets, Aurobindo Pharma,
Approval
July 25,
2007
July 24,
2007
July 23,
2007
|
Approval Information: Immune Globulin Intravenous (Human), 10% Liquid (Privigen) - CSL Behring AG
Posted: 7/27/2007, Approval Date: 7/26/2007
Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts - Agenda
Posted: 7/27/2007, Workshop Dates: 10/11-12/2007
Vacancy Announcement - Interdisciplinary Scientist, DHT/OCTGT
Posted: 7/27/2007
FDA Statement on Gene Therapy Clinical Trial
Posted: 7/27/2007
Field Correction of Transfer Sets Packed with Humate-P (CSL Behring LLC)
Posted: 7/25/2007; Date of Notification: 7/24/2007
Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets (Smiths Medical ASD, Inc.)
Posted: 7/25/2007; Date of Recall: 7/23/2007
Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996
Posted: 7/24/2007
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays
Posted: 7/24/2007
Substantially Equivalent 510(k) Device - Quality Donor System v2.1 - Talisman Ltd
Posted: 7/24/2007, Clearance Date: 7/16/2007
Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
Posted: 7/23/2007
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July
27, 2007 |
 |
Class
I Medical Device
Recall: Baxter
Healthcare Corp.
COLLEAGUE and
FLO-GARD Volumetric
Infusion Pumps
 |
|
|
Federal Register:
Circulatory System
Devices Panel of the
Medical Devices
Advisory Committee;
Notice of Meeting.
 |
|
|
Consumer Information
on: Cormet Hip
Resurfacing System -
P050016
|
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July
26, 2007 |
|
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Federal Register:
Draft Guidance for
Industry and Food
and Drug
Administration
Staff; In Vitro
Diagnostic
Multivariate Index
Assays;
Availability.
|
|
|
Class
I Medical Device
Recall: Thoratec
Paracorporeal
Ventricular Assist
System (PVAD)
|
|
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Class
I Medical Device
Recall: Thoratec
TLC-ll Portable
Ventricular Assist
Device (VAD) Driver
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July
25, 2007 |
|
|
Guidance for
Industry: Exports
Under the FDA Export
Reform and
Enhancement Act of
1996
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Questions and
Answers on HoMedics,
Inc. Heating Pads
and General Heating
Pad Safety
|
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|
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July
24, 2007 |
|
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Draft
Guidance for
Industry, Clinical
Laboratories, and
FDA Staff - In Vitro
Diagnostic
Multivariate Index
Assays |
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|
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CFR Rule Changes this week
14
-
20 - 510 - 514 - 516 |
|
Friday,
July 27, 2007 |
|
RULES
Advisory committees:
Risk Communication Advisory
Committee; establishment,
4122141222 [E714498]
[TEXT] [PDF]
NOTICES
Meetings:
Medical Devices Advisory Committee,
4133441335 [E714600]
[TEXT] [PDF]
|
|
Thursday,
July 26, 2007 |
RULES
Animal drugs, feeds, and
related products:
Minor uses or minor species;
new drugs designation,
4101041022 [E714444]
[TEXT] [PDF]
NOTICES
Reports and guidance
documents; availability,
etc.:
Cell selection devices for
point of care production of
minimally manipulated
autologous peripheral blood
stem cells,
4108041081 [073659]
[TEXT] [PDF]
In vitro diagnostic multivariate index assays,
4108141083 [073660]
[TEXT] [PDF]
Medical products; emergency use authorization,
4108341084 [073661]
[TEXT] [PDF]
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Wednesday,
July 25, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
4088540886 [E714403]
[TEXT] [PDF]
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Tuesday,
July 24, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
4030940310 [E714200]
[TEXT] [PDF]
4031040311 [E714201]
[TEXT] [PDF]
Committees; establishment,
renewal, termination, etc.:
National Mammography Quality
Assurance Advisory Committee
et al.,
4031140313 [E714206]
[TEXT] [PDF]
|
|
Monday,
July 23, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
4015740159 [E714149]
[TEXT] [PDF]
Meetings:
Cardiovascular and Renal
Drugs Advisory Committee and
Drug Safety and Risk
Management Advisory
Committee,
4015940160 [E714151]
[TEXT] [PDF]
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ICH
Q10 Step 3
US GMP Training Booklet
US GLP Trainer Booklet
US GCP Trainer Booklet
Combination Product handbook |
|
Standard-GMPs
Parts
11, 210, 211, 820 & ICH Q7A |
|
Med. Device -
11, 50, 54, 56, 807, 812,
814, 820, 510k/PMA |
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Clinical GCP -
Parts 11, 50, 54, 56, 312,
314 & ICH E2A & E6 |
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Multi-US GMPs 11, 58, 210/211, 600,
601, 610 & 820 |
|
Parts 210/211
- Drug GMPs |
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>210/211
with Part 11 |
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>210/211
with Part 820 |
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>210/211
with Parts 820 & 11 |
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>210/211 w/
Keyword Index |
Part 820
Quality Systems Regs
|
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Part 58 -
GLP Good Lab. Practice |
Part 11
- Electronic Records w/
Scope and Applications
|
GLP 2 11 & 58
- Part 11 & 58
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PDMA 11,
203 & 205 - Prescription
Drug Marketing
|
|
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11
& 820 Electronic Record and
Quality Systems
|
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