|
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 |
|
February 27, 2009
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Drug Shortages: Current
Drug Shortage: Oxycodone
Immediate Release
Tablets (5mg, 15mg and
30mg)
(updated)
-
New and Generic Drug
Approvals
-
Arthrotec
(diclofenac sodium
and misoprostol)
Delayed-Release
Tablets, G.D.
Searle, LLC,
Labeling Revision
-
Baraclude
(entecavir) Tablets,
Bristol-Myers Squibb
Co., Labeling
Revision
-
Baraclude
(entecavir) Oral
Solution,
Bristol-Myers Squibb
Co., Labeling
Revision
-
Cataflam
(diclofenac
potassium) Tablets,
Novartis
Pharmaceuticals
Corp., Labeling
Revision
-
Voltaren
(diclofenac sodium)
Delayed-Release
Tablets, Novartis
Pharmaceuticals
Corp., Labeling
Revision
-
Voltaren-XR
(diclofenac sodium)
Extended-Release
Tablets, Novartis
Pharmaceuticals
Corp., Labeling
Revision
February 26, 2009
-
Best Pharmaceuticals for
Children Act of 2007:
List of Determinations
Including Written
Request (updated)
-
DDMAC Letter to
Pharmaceutical
Companies:
Avodart (dutasteride)
Soft Gelatin Capsules
-
New and Generic Drug
Approvals
-
Carboplatin
I.V. Injection,
Pharmachemie B.V.,
Approval
-
Exidine
(chlorhexidine
gluconate) Topical
Solution, Xttrium
Laboratories, Inc.,
Package Change
-
Ofloxacin
Ophthalmic Solution,
FDC Ltd., Approval
-
Risperidone
Oral Solution,
Roxane Laboratories,
Inc., Tentative
Approval
-
Office of
Nonprescription
Products:
Listing of OTC Active
Ingredients
February 25, 2009
-
Clinical Trial Design
for Hospital-Acquired
Pneumonia and
Ventilator-Associated
Pneumonia Public
Workshop, March 31, 2009
and April 1, 2009,
Silver Spring, Maryland.
Public Workshop
Information
-
Drugs@FDA Downloadable
Data Files
(updated)
-
FDA takes new regulatory
action against Ranbaxy’s
Paonta Sahib plant in
India.
-
New and Generic Drug
Approvals
-
Amoxicillin and
Clavulanate
Potassium
Tablets, Apotex
Inc., Approval
-
Apidra
(insulin glulisine [rDNA
origin])
Subcutaneous I.V.
Injection, Sanofi
Aventis U.S., Inc.,
Package Change
-
Luvox
(fluvoxamine maleate)
Tablets, Jazz
Pharmaceuticals,
Labeling Revision
-
Luvox CR
(fluvoxamine maleate)
Extended-Release
Capsules, Jazz
Pharmaceuticals,
Labeling Revision
-
Revlimid
(lenalidomide)
Capsules, Celgene
Corp., Labeling
Revision
February 24, 2009
February 23, 2009
-
Drug Information
Association (DIA):
Cardiovascular Safety,
QT, and Arrhythmia
Assessment in Drug
Development, April
29-May 1, 2009, Hyatt
Regency Besthesda,
Bethesda, MD.
Meeting information
-
Drug Shortages: Current
Drug Shortage: Mitomycin
for injection
-
FDA issues Information
for Healthcare
Professionals for
Zonisamide.
Information
-
New and Generic Drug
Approvals
-
Carvedilol
Tablets, Hikma
Pharmaceuticals,
Labeling
-
ZANTAC
(ranitidine
hydrochloride)
Syrup,
GlaxoSmithKline,
Labeling Revision
-
ZANTAC 150/300
(ranitidine
hydrochloride)
Tablets,
GlaxoSmithKline,
Labeling Revision
-
ZANTAC 25/150
(ranitidine
hydrochloride)
Effervescent Tablets,
GlaxoSmithKline,
Labeling Revision
|
CDER
Drug Links
|
|
|
February 26, 2009 |
 |
Federal Register:
Agency Information
Collection
Activities;
Submission for
Office of Management
and Budget Review;
Comment Request;
Medical Device
Recall Authority
  |
|
|
|
February 25, 2009 |
|
|
Federal Register:
Agency Information
Collection
Activities; Proposed
Collection; Comment
Request; Medical
Device Reporting:
Manufacturer,
Importer, User
Facility, and
Distributor
Reporting
|
|
|
PMA Final Decisions
for January 2009
|
|
|
|
| News & Events |
National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Thinktank (April 27-28, 2009)
FDA Unique Device Identification Public Workshop: February 12, 2009
Public Health Notifications:
• Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
• Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory StatusClass I Medical Device Recalls -
• Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
• Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades
• Integra NeuroSciences, Gravity Compensating Accessory
• Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD)
Public Health Notifications:
• Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
• Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status |
Class I Medical Device Recalls -
• Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
• Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades
• Integra NeuroSciences, Gravity Compensating Accessory
• Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD) |
|
FDA Patient Safety News - A Video News Show for Health Professionals |
Medical Device Links
|
|
This
Week
Rule Changes:
21 CFR Parts -
17
CFR
Changes since April 1st. |
|
Friday,
Feb. 27, 2009 |
NONE
|
|
Thursday,
Feb. 26, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
8799–8801 [E9–4137]
[TEXT] [PDF]
|
|
Wed. Feb.
25, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
8549–8550 [E9–3938]
[TEXT] [PDF]
8547–8549 [E9–4057]
[TEXT] [PDF]
|
|
Tuesday,
Feb. 24, 2009 |
RULES
Maximum Civil Money Penalty
Amounts and Compliance,
etc.:
Confirmation of Effective
Date,
8200 [E9–3831]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals,
8262–8264 [E9–3916]
[TEXT] [PDF]
8264–8265 [E9–3917]
[TEXT] [PDF]
Meetings:
Arthritis Advisory
Committee; Postponement,
8266 [E9–3830]
[TEXT] [PDF]
Public Workshop:
Clinical Trial Design for
Hospital–Acquired Pneumonia
and Ventilator-Associated
Pneumonia,
8265–8266 [E9–3832]
[TEXT] [PDF]
|
|
Monday,
Feb. 23, 2009 |
|
NOTICES
Meetings:
Allergenic Products Advisory Committee
8093–8094 [E9–3786]
[TEXT] [PDF]
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