|
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 |
|
May 22,
2009
May 21,
2009
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Best Pharmaceuticals for
Children Act of 2007:
List of Determinations Including
Written Request (updated)
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Drug Shortages: Current Drug
Shortage: Technetium Tc99m
Generators
-
New
and Generic Drug Approvals
-
Advil
(ibuprofen) Tablets, Wyeth
Consumer Healthcare,
Labeling Revision
-
Advil Allergy Sinus
(clorpheniramine maleate,
ibuprofen and
pseudoephedrine
hydrochloride) Tablets,
Wyeth Consumer Healthcare,
Labeling Revision
-
Advil Cold & Sinus
(ibuprofen and
pseudoephedrine
hydrochloride) Capsules,
Wyeth Consumer Healthcare,
Labeling Revision
-
Advil Liqui-gels
(ibuprofen) Capsules, Wyeth
Consumer Healthcare,
Labeling Revision
-
Calcium Disodium Versenate
(edetate calcium disodium)
Injection, Graceway
Pharmaceuticals, LLC,
Labeling Revision
-
Children’s Advil
(ibuprofen) Oral Suspension,
Wyeth Consumer Healthcare,
Labeling Revision
-
Children’s Advil Cold
(ibuprofen and
pseudoephedrine
hydrochloride) Oral
Suspension, Wyeth Consumer
Healthcare, Labeling
Revision
-
Junior Strength Advil
(ibuprofen) Tablets, Wyeth
Consumer Healthcare,
Labeling Revision
-
Prograf
(tacrolimus) Capsules,
Astellas Pharma US, Inc.,
Labeling Revision
-
Prograf
(tacrolimus) Injection,
Astellas Pharma US, Inc.,
Labeling Revision
May 20,
2009
May 19,
2009
May 18,
2009
-
Adverse Event Reporting System (AERS)
Statistics
(updated)
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Drug Shortages: Current Drug
Shortage: Methotrexate injection
(updated)
-
Drug Shortages: Resolved Drug
Shortage: Enlon (edrophonium
chloride) injection and Enlon
Plus (edrophonium chloride and
atropine sulfate) injection
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New
and Generic Drug Approvals
-
Acarbose
Tablets, IMPAX Laboratories,
Inc., Approval
-
Adenosine
Injection, Strides Arcolab
Ltd., Approval
-
Chlorpheniramine Maleate
Extended-Release Tablets,
Avanthi, Inc., Approval
-
Coly-Mycin M
(colistimethate sodium)
Injection, JHP
Pharmaceuticals, LLC.,
Labeling Revision
-
Levofloxacin
Tablets, Lupin Ltd.,
Approval
-
Losartan Potassium and
Hydrochlorothiazide
Tablets, Roxane
Laboratories, Inc.,
Tentative Approval
-
Meloxicam
Tablets, Strides Arcolab
Ltd., Approval
-
Moxifloxacin Hydrochloride
Ophthalmic Solution, Teva
Parenteral Medicines, Inc.,
Tentative Approval
-
Quadramet
(samarium sm 153 lexidronam
pentasodium) Injection, EUSA
Pharma Inc., Expiration Date
Change
-
Risperdal CONSTA
(risperidone) Intramuscular
Injection, Johnson & Johnson
Pharmaceutical, New or
Modified Indication
-
Ropivacaine Hydrochloride
Injection, Navinta LLC,
Tentative Approval
-
Roxicodone
(oxycodone hydrochloride)
Tablets, Xanodyne
Pharmaceuticals, Inc.,
Formulation Revision
-
Ursodiol
Tablets, TEVA
Pharmaceuticals, Approval
CDER
Drug Links
|
Hot Topics
H1N1 Virus (Flu)
Information
GARDASIL (Human Papillomavirus
Vaccine)
Zostavax (Herpes Zoster Vaccine)
Advisory Committees
Blood
Establishment Registration
FDA's
Office of Criminal Investigations (OCI)
Forms
Guidances/Guidelines/Points to
Consider
Impact
of Severe Weather Conditions on
Biological Products
Proposed and Final Rules
Human
Cell and Tissue Establishment
Registration
Recall
& Product Withdrawals
Reporting Adverse Events and Product
Deviations
Safety
Information
Shortages
What's
New
CBER Links
|
|
May 21, 2009 |
 |
Circulatory System
Devices Panel
Advisory Meeting,
April 23, 2009 -
Transcript
 |
|
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Neurological Devices
Panel Advisory
Meeting, May 14,
2009 - Slides
|
|
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Federal Register:
Temporary Deferment
of Activities
Relating to Medical
Device Submissions
 |
|
|
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May 20, 2009 |
|
|
Federal Register:
Agency Information
Collection
Activities;
Submission for
Office of Management
and Budget Review;
Comment Request;
Electronic Data
Collection Using
MedWatch\Plus\
Portal and Rational
Questionnaire
|
|
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Federal Register:
Gastroenterology and
Urology Devices
Panel of the Medical
Devices Advisory
Committee; Notice of
Meeting
|
|
|
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May 19, 2009 |
|
|
Federal Register:
Agency Information
Collection
Activities;
Submission for
Office of Management
and Budget Review;
Comment Request;
Medical Device
Reporting:
Manufacturer,
Importer, User
Facility, and
Distributor
Reporting
|
|
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May 18, 2009 |
|
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Class I Medical
Device Recall:
Respironics, Inc.,
SmartMonitor 2
Infant Apnea Monitor
(Models 4002 and
4003)
|
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This
Week
Rule Changes:
21 CFR Parts - NONE |
|
Friday,
May 22, 2009 |
NOTICES
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
INTELENCE
24014–24015 [E9–12050]
[TEXT] [PDF]
Public Workshop:
Food and Drug Administration
Clinical Trial Requirements
24022 [E9–12051]
[TEXT] [PDF]
|
|
Thursday,
May 21, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
23865–23866 [E9–11931]
[TEXT] [PDF]
Temporary Deferment of
Activities Relating to
Medical Device Submissions
23874 [E9–11840]
[TEXT] [PDF]
|
|
Wednesday.
May 20, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
23721–23727 [E9–11687]
[TEXT] [PDF]
Meetings:
Gastroenterology and Urology
Devices Panel of the Medical
Devices Advisory Committee
23731–23732 [E9–11734]
[TEXT] [PDF]
|
|
Tuesday,
May 19, 2009 |
NOTICES
Withdrawal of Approval of 92
New Drug and 49 Abbreviated
New Drug Applications:
Novartis Pharmaceuticals
Corp. et al.
23407–23412 [E9–11628]
[TEXT] [PDF]
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
23413–23414 [E9–11625]
[TEXT] [PDF]
Meetings:
Gastrointestinal Drugs
Advisory Committee;
Cancellation
23426 [E9–11725]
[TEXT] [PDF]
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Monday,
May 18, 2009 |
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NONE
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