|
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
24, 2009
April
23, 2009
-
Approved Drug Products with
Therapeutic Equivalence
Evaluations Orange Book
(updated)
-
Drugs@FDA Downloadable Data
Files
(updated)
-
FDA
updates action on Plan B (levonorgestrel)
tablets.
FDA Statement
-
New
and Generic Drug Approvals
-
Kaletra
(lopinavir and ritonavir)
Tablets, Abbott
Laboratories, Efficacy
Supplement with Clinical
Data to Support
-
Kaletra
(lopinavir and ritonavir)
Oral Solution, Abbott
Laboratories, Efficacy
Supplement with Clinical
Data to Support
-
Lovaza
(omega-3-acid ethyl esters)
Capsules, GlaxoSmithKline,
Labeling Revision
-
Omeprazole
Delayed-Release Capsules,
Dr. Reddy's Laboratories,
Ltd., Approval
-
Prismasol
(calcium chloride, dextrose,
lactic acid, magnesium
chloride, potassium
chloride, sodium bicarbonate
and sodium chloride)
Injection, Gambro, Package
Change
-
Topiramate
Capsules, Teva
Pharmaceuticals USA,
Approval
April
22, 2009
April
21, 2009
-
Warning Letter issued to Ronald
Bukowski, M.D.
-
New
and Generic Drug Approvals
-
Aleve-D Sinus & Cold
(naproxen sodium and
pseudoephedrine
hydrochloride)
Extended-Release Tablets,
Bayer HealthCare Consumer
Care, Labeling Revision
-
Doxycycline
Tablets, Mutual
Pharmaceutical Co., Inc.,
Approval
-
Metadate CD
(methylphenidate
hydrochloride)
Extended-Release Capsules,
UCB, Inc., Labeling Revision
-
Savella
(milnacipran hydrochloride)
Tablets, Cypress Bioscience,
Inc., Control Supplement
April
20, 2009
-
Drug Shortages: Resolved Drug
Shortage: Acyclovir Injection
-
Guidance for Industry:
Integrated Summaries of
Effectiveness and Safety:
Location Within the Common
Technical Document [PDF]
-
Medical, Statistical, and
Clinical Pharmacology Reviews of
Pediatric Studies
(updated)
-
New
and Generic Drug Approvals
-
Aleve
(naproxen sodium) Tablets,
Bayer HealthCare LLC,
Labeling Revision
-
Topiramate
Capsules, Barr Laboratories,
Inc., Approval
-
Topiramate
Capsules, Zydus
Pharmaceuticals USA Inc.,
Tentative Approval
-
Topiramate
Capsules, Sandoz Inc.,
Tentative Approval
-
Topiramate
Capsules, Cobalt
Laboratories Inc., Approval
-
Paragraph IV Patent
Certifications
(updated)
-
Quality Risk Management
Implementation Strategies; U.S.
FDA/CDER and University of Rhode
Island College of Pharmacy
Conference, June 15-16, 2009,
Hyatt Regency Bethesda,
Bethesda, Maryland.
Meeting Information.
CDER
Drug Links
|
Hot Topics
CBER Links
|
|
April 22, 2009 |
 |
Federal Register:
Agency Information
Collection
Activities;
Submission for
Office of Management
and Budget Review;
Comment Request;
Financial Disclosure
by Clinical
Investigators
  |
|
|
|
April 21, 2009 |
|
|
Circulatory System
Devices Panel
Advisory Meeting,
April 23, 2009 -
Agenda, Roster,
Briefing, Questions
|
|
|
|
|
This
Week
Rule Changes:
21 CFR Part
589
CFR
Changes since April 2008 |
|
Friday,
April
24, 2009 |
RULES
Substances Prohibited From
Use in Animal Food or Feed:
Confirmation of Effective
Date of Final Rule
1862618628 [E99466]
[TEXT] [PDF]
NOTICES
Meetings:
Drug Safety and Risk
Management Advisory
Committee, et al.
1873118733 [E99380]
[TEXT] [PDF]
Small Entity Compliance
Guide on Prior Notice of
Imported Food; Availability
1873618737 [E99358]
[TEXT] [PDF]
|
|
Thursday,
April 23, 2009 |
|
NONE |
|
Wednesday.
April 22, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
1838518386 [E99148]
[TEXT] [PDF]
|
|
Tuesday,
April 21, 2009 |
NOTICES
Guidance for Industry on
Integrated Summaries of
Effectiveness and Safety:
Location Within the Common
Technical Document;
Availability
18241 [E99051]
[TEXT] [PDF]
|
|
Monday,
April 20 2009 |
|
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
1796217964 [E98922]
[TEXT] [PDF]
Meetings:
Risk Evaluation and Mitigation Strategies for Certain
Opioid Drugs
1796717970 [E98992]
[TEXT] [PDF]
|
|
|
.jpg)
