|
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 |
|
March 6, 2009
March 5, 2009
March 4, 2009
March 3, 2009
-
Drug Shortages: Resolved
Drug Shortage: Ultra-TechneKow
DTE (Technetium Tc 99m
Generator) NDA 17-243
-
Guidance for Industry:
Clinical Pharmacology
Section of Labeling for
Human Prescription Drug
and Biological
ProductsContent and
Format [PDF]
-
Medical, Statistical,
and Clinical
Pharmacology Reviews of
Pediatric Studies
(updated)
-
New and Generic Drug
Approvals
-
Capozide
(captopril and
hydrochlorothiazide)
Tablets,
Bristol-Myers
Squibb, Labeling
Revision
-
Divalproex Sodium
Extended-Release
Tablets, Anchen
Pharmaceuticals
(Taiwan), Inc.,
Approval
-
Divalproex Sodium
Extended-Release
Tablets, Zydus
Pharmaceuticals USA
Inc., Approval
-
Granisetron
Hydrochloride
Tablets, Dr. Reddy's
Laboratories Inc.,
Approval
-
Heparin Sodium
20,000 Units in
Dextrose 5% in
Plastic Container
Injection, B. Braun
Medical Inc.,
Labeling Revision
-
Heparin Sodium 1,000
Units in Sodium
Chloride 0.9% in
Plastic Container
Injection, B. Braun
Medical Inc.,
Labeling Revision
-
Myoview
(technetium tc-99m
and tetrofosmin kit)
Injection, GE
Healthcare,
Formulation Revision
-
Symbicort
(budesonide and
formoterol fumarate
dihydrate)
Inhalation Spray,
AstraZeneca LP, New
or Modified
Indication
-
Paragraph IV Patent
Certifications
(updated)
March 2, 2009
|
CDER
Drug Links
|
|
|
March 5, 2009 |
 |
510(k) Final
Decisions - February
2009
 |
|
|
FDA Public Health
Advisory - Risk of
Burns during MRI
Scans from
Transdermal Drug
Patches with
Metallic Backings
|
|
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FDA Warns About Risk
of Wearing Medicated
Patches During MRIs
|
|
|
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March 3, 2009 |
|
|
Consumer Information
on: Reclaim DBS
Therapy for OCD -
H050003
|
|
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Summary Information
for: Reclaim Deep
Brain Stimulation
for Obsessive
Compulsive Disorder
(OCD) Therapy
 |
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| 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 -
310 -
347 - 510 - 529 - 314
-
522
CFR
Changes since April 1st. |
|
Friday,
March 06, 2009 |
RULES
Astringent Drug Products
That Produce Aluminum
Acetate; Skin Protectant
Drug Products for
Over-the-Counter Human Use;
Technical Amendment
97599765 [E94746]
[TEXT] [PDF]
New Animal Drugs; Change of
Sponsor:
Methoxyflurane
97669767 [E94758]
[TEXT] [PDF]
New Drug Applications and
Abbreviated New Drug
Applications; Technical
Amendment
97659766 [E94813]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
98209822 [E94750]
[TEXT] [PDF]
98229823 [E94766]
[TEXT] [PDF]
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
ARRANON
98239824 [E94770]
[TEXT] [PDF]
|
|
Thursday,
March 05, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
96189619 [E94644]
[TEXT] [PDF]
Meetings:
Risk Communication Advisory
Committee
96199620 [E94645]
[TEXT] [PDF]
|
|
Wed. March
04, 2009 |
NOTICES
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
SOLIRIS
9406 [E94526]
[TEXT] [PDF]
Meetings:
Psychopharmacologic Drugs
Avisory Committee,
94069407 [E94523]
[TEXT] [PDF]
|
|
Tuesday,
March 03, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
92479249 [E94457]
[TEXT] [PDF]
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
ENDEAVOR
92499250 [E94374]
[TEXT] [PDF]
Reports and Guidance
Documents; Availability,
etc.:
Guidance for Industry
Clinical Pharmacology
Section of Labeling for
Human Prescription Drug and
Biological Products
92509251 [E94372]
[TEXT] [PDF]
|
|
Monday,
March 02, 2009 |
|
RULES
Implantation or Injectable
Dosage Form New Animal
Drugs; Ivermectin,
9049 [E94304]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals,
90979098 [E94315]
[TEXT] [PDF]
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