|
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 |
April
17, 2009
-
Inactive Ingredient Search for
Approved Drug Products (updated)
-
Investigational Human Drugs:
Clinical Investigator Inspection
List
(updated)
-
New
and Generic Drug Approvals
-
Dorzolamide Hydrochloride
Ophthalmic Solution, Alcon,
Inc., Approval
-
Lexiva
(fosamprenavir calcium)
Tablets, GlaxoSmithKline,
Labeling Revision
-
Lexiva
(fosamprenavir calcium) Oral
Suspension, GlaxoSmithKline,
Labeling Revision
-
Mitoxantrone Hydrochloride
Injection, GeneraMedix,
Inc., Approval
-
Ondansetron Hydrochloride
and Dextrose in Plastic
Container
Injection, Bedford
Laboratories, Approval
-
Suprane
(desflurane) Inhalation
Liquid, Baxter Healthcare
Corp., Labeling Revision
-
Zoledronic Acid
I.V. Injection, Apotex,
Inc., Tentative Approval
April
16, 2009
-
Guidance for Industry:
Submission of Summary
Bioequivalence Data for ANDAs [PDF]
-
New
and Generic Drug Approvals
-
Amlodipine Besylate
Tablets, Glenmark Generics,
Ltd., Approval
-
Benzyl Alcohol
(benzyl alcohol) Lotion,
Sciele Pharma, Inc.,
Approval
-
Coartem
(artemether and lumefantrine)
Tablets, Novartis
Pharmaceuticals Corp.,
Approval
-
Depo-Medrol
(methylprednisolone acetate)
Injection, Pfizer Global
Research and Development,
Labeling Revision
-
Detrol
(tolterodine tartrate)
Tablets, Pfizer Global
Research and Development,
Labeling Revision
-
Extraneal
(icodextrin) Peritoneal
Solution, Baxter Healthcare
Corp., Labeling Revision
-
Mavik
(trandolapril) Tablets,
Abbott Laboratories (GPRA),
Labeling Revision
-
Norethindrone, Ethinyl
Estradiol, and Ferrous
Fumarate
Chewable Tablets, Barr
Laboratories, Inc., Approval
-
Oxycodone Hydrochloride
Tablets, Sun Pharmaceutical
Industries, Inc., Approval
-
Ranitidine
Syrup, Dr. Reddy's
Laboratories, Ltd.,
Tentative Approval
-
Requip XL
(ropinirole hydrochloride)
Extended-Release Tablets,
GlaxoSmithKline, Formulation
Revision
-
Office of Generic Drugs:
Determination of Topiramate
Sprinkle Capsules Exclusivity
April
15, 2009
April
14, 2009
CDER
Drug Links
|
Hot Topics
CBER Links
|
|
April 17, 2009 |
 |
Consumer Information
on: ARCHITECT CORE
Reagent Kit,
Calibrator and
Controls - P080023
 |
|
|
Federal Register:
Draft Guidance for
Industry and Food
and Drug
Administration
Staff:
Investigational
Device Exemption
Guidance for Retinal
Prostheses
 |
|
|
Consumer Information
on: Medtronic Attain
Ability Model 4196
Lead - P080006
|
|
|
Orthopaedic and
Rehabilitation
Devices Panel
Advisory Meeting,
March 31, 2009 -
Agenda, Roster,
Briefing, Questions,
Brief Summary,
Slides
|
|
|
|
April 16, 2009 |
|
|
Draft Guidance for
Industry and FDA
Staff:
Investigational
Device Exemption
(IDE) Guidance for
Retinal Prostheses
|
|
|
FDA / NHLBI / NSF
Workshop on Computer
Methods for
Cardiovascular
Devices, June 1-2,
2009
|
|
|
|
April 15, 2009 |
|
|
Class I Medical
Device Recall:
Teleflex Medical,
Arrow International
Inc. 30, 40, and 50
cc Intra-Aortic
Balloons
|
|
|
|
April 13, 2009 |
|
|
Summary Information
for: Cervista HPV
16/18
|
|
|
Consumer Information
on: Cervista HPV
16/18 - P080015
|
|
|
Consumer Information
on: CervistaTM HPV
HR and GenfindTM DNA
Extraction Kit -
P080014
|
|
|
Summary Information
for: CervistaTM HPV
HR and GenfindTM DNA
Extraction Kit
|
|
|
Consumer Information
on: FC2 Female
Condom - P080002
|
|
|
Consumer Information
on: Synvisc-One (hylan
GF-20) - P940015S012
|
|
|
|
|
This
Week
Rule Changes:
21 CFR Part
520
CFR
Changes since April 2008 |
|
Friday,
April
17, 2009 |
RULES
Oral Dosage Form New Animal
Drugs:
Fenbendazole Suspension
17770 [E98822]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
1786817869 [E98773]
[TEXT] [PDF]
17871 [E98776]
[TEXT] [PDF]
17871 [E98836]
[TEXT] [PDF]
Draft Guidance for Industry
and Food and Drug
Administration Staff:
Investigational Device
Exemption Guidance for
Retinal Prostheses
17872 [E98774]
[TEXT] [PDF]
Draft Guidance for Industry:
Submission of Summary Bioequivalence Data for
Abbreviated New Drug
Applications
1787217873 [E98833]
[TEXT] [PDF]
|
|
Thursday,
April 16, 2009 |
|
NONE |
|
Wednesday.
April 15, 2009 |
NOTICES
Meetings:
Preparation for
International Conference on
Harmonisation Meetings in
Yokohama, Japan
1750017501 [E98679]
[TEXT] [PDF]
|
|
Tuesday,
April 14, 2009 |
NOTICES
Determinations:
ZOMETA (Zoledronic Acid for
Injection)
1719617197 [E98524]
[TEXT] [PDF]
|
|
Monday,
April 13, 2009 |
|
NONE
|
|
|
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