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 25,
2008
April 24,
2008
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New and Generic
Drug Approvals
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Actonel
(risedronate sodium)
Tablets, Procter & Gamble,
Labeling Revision
-
Actonel
(risedronate sodium)
Tablets, Procter & Gamble,
New Dosage Regimen
-
Declomycin
(demeclocycline
hydrochloride) Tablets,
Stiefel Labs, Labeling
Revision
-
Vyvanse
(lisdexamfetamine dimesylate)
Capsule, New River
Pharmacueticals, Patient
Population Altered
- Office of
Nonprescription Products:
Rx to OTC Switch (updated)
April 23,
2008
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Drugs@FDA
Downloadable Data Files
(updated)
-
New and Generic
Drug Approvals
-
Aplenzin
(bupropion hydrobromide)
Extended-Release Tablets,
Biovail Labs, Approval
-
Cabergoline
Tablets, Cobalt Labs,
Approval
-
Children's
Cetirizine Hydrochloride
Allergy
Syrup, Taro Pharma, Approval
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Children's
Cetirizine Hydrochloride
Hives Relief
Syrup, Taro Pharma, Approval
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Irinotecan
Hydrochloride
Injection, Sun Pharma,
Approval
-
Prevacid
(lansoprazole)
Delayed-Release Oral
Suspension, TAP Pharma,
Labeling Revision
-
Prevacid
(lansoprazole)
Delayed-Release Capsules,
TAP Pharma, Labeling
Revision
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Prevacid
(lansoprazole)
Delayed-Release Orally
Disintegrating Tablets, TAP
Pharma, Labeling Revision
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Topiramate
Tablets, Apotex, Tentative
Approval
April 22,
2008
-
FDA approves
Cimzia (certolizumab pegol) to
treat Crohn's disease
-
Medical,
Statistical, and Clinical
Pharmacology Reviews of
Pediatric Studies
(updated)
-
New and Generic
Drug Approvals
-
Ciprofloxacin
in Dextrose 5% in Plastic
Container
Injection, Hikma
Farmaceutica, Approval
-
Enablex
(darifenacin hydrobromide)
Extended Release Tablets,
Novartis Pharma, Labeling
Revision
-
Hydrocodone
Bitartrate and Acetaminophen
Oral Solution,
Pharmaceutical Assoc.,
Approval
-
Singulair
(montelukast sodium)
Tablets, Merck & Co.,
Labeling Revision
-
Singulair
(montelukast sodium)
Chewable Tablets, Merck &
Co., Labeling Revision
-
Singulair
(montelukast sodium) Oral
Granules, Merck & Co.,
Labeling Revision
-
Tigan
(trimethobenzamide
hydrochloride) Intramuscular
Injection, JHP Pharma,
Labeling Revision
-
Warning Letter:
Peridex Zila Pharmaceuticals,
Inc.
April 21,
2008
-
CDER updates
Information on Adverse Event
Reports and Heparin
-
FDA issues a map
of Countries with Contaminated
Heparin API
- FDA/DIA
co-sponsored conference:
Emerging Regulatory Issues in
Genomic Medicine, May 21-23,
Mexico City, Mexico.
Meeting information and
registration
-
New and Generic
Drug Approvals
-
AUGMENTIN
ES-600
(amoxicillin, clavulanate
potassium) Powder for Oral
Suspension, GlaxoSmithKline,
Labeling Revision
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AUGMENTIN XR
(amoxicillin, clavulanate
potassium) Extended Release
Tablets, GlaxoSmithKline,
Labeling Revision
-
COPEGUS
(ribavirin) Tablets, Roche,
Labeling Revision
-
Crixivan
(indinavir sulfate)
Capsules, Merck & Co.,
Labeling Revision
-
Cyclobenzaprine
Hydrochloride
Tablets, Amneal Pharma,
Approval
-
Felodipine
Extended-release Tablets,
Mylan Pharma, Approval
-
Metformin
Hydrochloride
Extended-Release Tablets,
NeuroSci Inc., Approval
-
Oxacillin
(oxacillin sodium)
Injection, Baxter
Healthcare, Labeling
Revision
-
Synthroid
(levothyroxine sodium)
Tablets, Abbott Labs,
Labeling Revision
-
Timentin in
Plastic Container
(ticarcillin disodium,
clavulanate potassium)
Injection, GlaxoSmithKline,
Labeling Revision
-
Timentin
(ticarcillin disodium,
clavulanate potassium)
Injection, GlaxoSmithKline,
Labeling Revision
-
Zosyn
(piperacillin sodium,
tazobactam sodium)
Injection, Wyeth Pharma,
Labeling Revision
-
Zosyn in
Plastic Container
(piperacillin sodium,
tazobactam sodium)
Injection, Wyeth Pharma,
Labeling Revision
-
Warning Letter:
Inspection; Changzhou SPL
Company, Ltd.
-
Warning Letter:
CDER Drug Links
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Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Posted: 4/25/2008Rotavirus Vaccine, Live, Oral (ROTARIX) - Summary Basis for Regulatory Action
Posted: 4/25/2008
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies
Posted: 4/25/2008, Publish Date: 4/24/2008
Product Correction: Hepatitis B Surface Antigen AUSAB EIA - Abbott Laboratories
Posted: 4/24/2008, Notification Date: 4/21/2008
Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc
Posted: 4/24/2008, Notification Date: 4/21/2008
Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Agenda
Posted: 4/23/2008
Vacancy Announcement - Supervisory Interdisciplinary, DBA/OBRR
Posted: 4/23/2008
Recall: Rho(D) Immune Globulin (Human); Hyper RHO S/D, Mini-Dose - Talecris Biotherapeutics, Inc
Posted: 4/21/2008, Recall Date: 4/18/2008
Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc
Posted: 4/21/2008, Notification Date: 3/26/2008
Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007
Posted: 4/21/2008
CBER Links
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April 25, 2008 |
 |
FDA Clears Glove
Made from New
Type of Latex
 |
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April 24, 2008 |
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Summary
Information for:
CONTAK RENEWAL 3
AVT Models M150,
M155, M157 and
M159
 |
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Federal
Register: Draft
Guidance for
Industry on
Developing
Coronary Drug
Eluting Stents:
Public Workshop.
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Federal
Register: Agency
Information
Collection
Activities;
Proposed
Collection;
Comment Request;
Medical Device
Labeling
Regulations.
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Guidance for
Industry and FDA
Staff:
Hemodialysis
Blood Tubing
Sets - Premarket
Notification
[510(k)]
Submissions
(Updated
4/24/2008)
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Federal
Register:
Obstetrics and
Gynecology
Devices Panel of
the Medical
Devices Advisory
Committee;
Notice of
Postponement of
Meeting.
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Summary
Information for:
Talent Abdominal
Stent Graft
System
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April 23, 2008 |
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Ophthalmic
Devices Panel
Advisory
Meeting, April
24-25, 2008 -
Agenda, Roster,
Briefing,
Questions
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April 22, 2008 |
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Federal
Register: Agency
Information
Collection
Activites;
Submission for
Office of
Management and
Budget Review;
Comment Request;
Medical Devices;
Device Tracking.
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Medical Device Links
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NEW! - EU GMPs & US GMPs
in one
small handbook!
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Weekly Rule Changes
589 -
522 -
556 |
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Friday,
April 25, 2008 |
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RULES
Substances Prohibited From
Use in Animal Food or Feed,
2272022758 [081180]
[TEXT] [PDF]
NOTICES
Agency
Information Collection
Activities; Proposals,
Submissions, and Approvals,
2242322424 [E88973]
[TEXT] [PDF]
Guidance for Industry;
Availability:
EPA White Paper Regarding StarLink Corn Dietary
Exposure and Risk,
22716 [E89003]
[TEXT] [PDF]
Withdrawal of Guidance for
Industry:
Recommendations for Sampling and Testing Yellow Corn
and Dry-Millled Yellow Corn
Shipments for Cry9C Protein
Residues,
2271622717 [E88805]
[TEXT] [PDF]
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Thursday,
April 24, 2008 |
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NOTICES
Draft Guidance for Industry
on Developing Coronary Drug
Eluting Stents; Public
Workshop,
2215622157 [E88853]
[TEXT] [PDF]
Meetings:
Obstetrics and Gynecology
Devices Panel of the Medical
Devices Advisory Committee,
22157 [E88845]
[TEXT] [PDF]
Report on the Performance of
Drug and Biologics Firms in
Conducting Postmarketing
Commitment Studies;
Availability,
2215722159 [E89007]
[TEXT] [PDF]
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Wed.,
April 23, 2008 |
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RULES
New Animal Drugs;
Enrofloxacin,
21819 [E88713]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals,
2195921962 [E88710]
[TEXT] [PDF]
Public Workshop:
Developing Guidance on
Pharmacoepidemiologic Safety
Studies
Conducting Scientifically
Sound Safety Studies Using
Large Electronic Healthcare
Data Sets,
2196321964 [E88772]
[TEXT] [PDF]
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Tuesday,
April 22, 2008 |
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NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals,
21631 [E88680]
[TEXT] [PDF]
2163121632 [E88682]
[TEXT] [PDF]
Meetings:
Anesthetic and Life Support Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory
Committee,
2163221633 [E88683]
[TEXT] [PDF]
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Monday,
April 21, 2008 |
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NOTICES
Meeting to Present Changes
to the Animal Feed Safety
System Project:
Ranking of Feed Hazards According to the Risks They
Pose to Animal and Public
Health,
2135521357 [081154]
[TEXT] [PDF]
Opportunity for Public Input
on Standards for Pet Food
and Other Animal Feeds:
Notice of Meeting,
2135721359 [081155]
[TEXT] [PDF]
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EU - US - ICH GMP
Combination Product
handbook |
|
US GMP Training Booklet |
|
Std. GMPs
- Parts 11, 210, 211, 820 &
ICH Q7 |
|
Med. Device - 11, 50,
54, 56, 807, 812, 814, 820,
510k/PMA |
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Clinical GCP - Parts 11,
50, 54, 56, 312, 314 & ICH
E2A & E6 |
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Multi-US GMPs 11, 58,
210/211, 600, 601, 610
& 820 |
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Parts 210/211 - Drug
GMPs |
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>210/211
with Part 11 |
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>210/211
with Part 820 |
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>210/211
with Parts 820 & 11 |
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>210/211
w/ Keyword Index |
Part 820
Quality Systems Regs
|
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Part 58 - GLP Good
Lab. Practice |
Part 11
- Electronic Records w/
Scope and Applications
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GLP 2 11 & 58 - Part 11
& 58
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PDMA 11,
203 & 205 - Prescription
Drug Marketing
|
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11
& 820 Electronic Record
and Quality Systems
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