Center
for Drug Evaluation &
Research (CDER) News |
(CBER) Center
for Biologics Evaluation & Research |
Center
for Device & Radiological
Health (CDRH) |
Federal Register -
Meetings, Notices, & Rule Changes |
|
CDER Links |
CBER Links |
CDRH Links |
May 11, 2007
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New and Generic
Drug Approvals
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Cefazolin
Injection, Sandoz Inc.,
Approval
-
Cefdinir
Capsules, Teva Pharma,
Approval
-
ChloraPrep
(2% chlorhexidine gluconate
(w/v) topical solution),
Enturia Inc., Labeling
Revision
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Clindamycin
Injection, Abraxis Pharma,
Approval
-
Neupro
(rotigotine) Transdermal
System, Schwarz BioSciences,
Approval
-
Oxybutynin
Chloride Extended-Release
Tablets, Impax Labs, Control
Supplement
May 10,
2007
- Guidance for
Industry:
Computerized
Systems Used in Clinical Trials
[PDF]
- FDA approves
Neupro (rotigotine transdermal
system), a skin patch designed
to treat symptoms of early
Parkinson's disease.
FDA News
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New and Generic
Drug Approvals
-
Cefdinir
Oral Suspension, Lupin
Pharma, New Strength
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Irbesartan
and Hydrochlorothiazide
Tablets, Teva Pharma,
Tentative Approval
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Pramipexole
Dihydrochloride Tablets,
Mylan Pharma, Tentative
Approval
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Trizivir
(abacavir sulfate/lamivudine/zidovudine)
Tablets, GlaxoSmithKline,
Labeling Revision
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Valproic
Acid Oral Solution, Vintage
Pharma, Labeling
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Ziagen
(abacavir sulfate) Tablets,
GlaxoSmithKline, Labeling
Revision
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Ziagen
(abacavir sulfate) Oral
Solution, GlaxoSmithKline,
Labeling Revision
May 9,
2007
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Drugs@FDA
Downloadable Data Files
(updated)
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New and Generic
Drug Approvals
-
Alprazolam
Tablets, Alphapharm,
Labeling
-
Cefdinir
Oral Suspension, Teva Pharma,
Approval
-
Epzicom
(abacavir sulfate and
lamuvidine) Tablets,
GlaxoSmithKline, Labeling
Revision
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Gemcitabine
Injection, Sicor Pharma,
Tentative Approval
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Haldol
(haloperidol) Injection,
Johnson & Johnson, Labeling
Revision
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Haldol
Decanoate
(haloperidol) IM Injection,
Johnson & Johnson, Labeling
Revision
-
Metadate
CD (methylphenidate HCl)
Extended-Release Capsules,
UCB Inc., Labeling Revision
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Promethazine
Hydrochloride Tablets, KVK-Tech
Inc., New Strength
- Notice of
Violation Letter:
-
Orange Book
Current Cumulative Supplement
-
Orange Book
Information and Data Files
-
Orange Book
Monthly Additions and Deletions:
April 2007
-
Orange Book Query
May 8,
2007
May 7,
2007
-
New and Generic
Drug Approvals
-
Concerta
(methylphenidate
hydrochloride)
Extended-Release Tablets,
Johnson & Johnson, Labeling
Revision
-
Finasteride
Tablets, Teva Pharma,
Tentative Approval
-
Fosphenytoin
Sodium Injection, Baxter
Healthcare, Tentative
Approval
-
Irinotecan
Hydrochloride Injection,
Watson Labs, Tentative
Approval
-
Ortho-Cyclen
(norgestimate/ethinyl
estradiol) Tablets, Johnson
& Johnson, Labeling Revision
-
Ortho Tri-Cyclen
(norgestimate/ethinyl
estradiol) Tablets, Johnson
& Johnson, Labeling Revision
-
Renacidin
Irrigation, United Guardian
Inc., Manufacturing Change
or Addition
-
Supprelin
LA (histrelin acetate)
Subcutaneous Implant,
Indevus Pharma, Approval
-
Zolpidem
Tartrate Tablet, Aurobindo
Pharma, Approval
- BPCA/Pediatric
Exclusivity Statistics:
|
2007 Biological Approvals - Update
Posted: 5/11/2007Supplement Approval: Fibrin Sealant (Human) (Evicel) - Omrix biopharmaceuticals Ltd
Posted: 5/11/2007, Approval Date: 5/9/2007
Guidance for Industry: Computerized Systems Used in Clinical Investigations
Posted: 5/10/2007, Publish Date: 5/10/2007
Biological Product Shortages - ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), Merck & Co, Inc.
Posted: 5/10/2007
Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
Posted: 5/10/2007, Publish Date: 5/10/2007
SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants - Update
Posted: 5/8/2007
SOPP 8104: Documentation of Telephone Contacts with Regulated Industry - Update
Posted: 5/8/2007
Approved Biological NDA and ANDA Applications - Update
Posted: 5/7/2007, Updated through: 4/30/2007
Cleared Biological 510(k) Device Applications - Update
Posted: 5/7/2007, Updated through: 4/30/2007
Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 5/7/2007, Updated through: 4/30/2007
Licensed Products and Establishments List - Update
Posted: 5/7/2007, Updated through: 4/30/2007
Alpha-1-Proteinase Inhibitor (Human) (Aralast NP), Baxter Healthcare Corporation
Posted: 5/7/20007; Approval Date: 5/4/2007
Heterogeneity of Alpha-1 Proteinase Inhibitor (Human) Products - Update
Posted: 5/7/2007
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May
11, 2007 |
 |
Summary Information
for: C-flex Model
570C Intraocular
Lens (IOL)
 |
|
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Circulatory System
Devices Panel
Advisory Meeting,
June 27, 2007 -
Notice of Meeting
 |
|
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Consumer Information
on: EMS Swiss
Dolorclast - P050004
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Nationwide
Evaluation of X-Ray
Trends (NEXT) -
Tabulation and
Graphical Summary of
2000 Survey of
Computed Tomography
|
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Summary Information
for: Perlane
Injectable Gel
|
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Summary Information
for: Vascular
Solutions D-Star
Flowable Hemostat
|
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May
10, 2007 |
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Federal Register:
Circulatory System
Devices Panel of the
Medical Devices
Advisory Committee;
Notice of Meeting.
|
|
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FDA
Clears First
Respirators for Use
in Public Health
Medical Emergencies
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May
9, 2007 |
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Federal Register:
Guidance for
Industry and Food
and Drug
Administration
Staff; Class II
Special Controls
Guidance Document:
Gene Expression
Profiling Test
System for Breast
Cancer Prognosis;
Availability.
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|
|
Consumer Information
on: IBI Therapy Cool
Path Ablation
Catheter and IBI
1500T9 RF Generator
- P060019
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Federal Register:
Medical Devices;
Immunology and
Microbiology
Devices;
Classification of
Gene Expression
Profiling Test
System for Breast
Cancer Prognosis.
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May
8, 2007 |
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Federal Register:
Draft Guidance for
Industry and Food
and Drug
Administration
Staff; Class II
Special Controls
Guidance Document:
Absorbable
Hemostatic Device;
Availability;
Reopening of Comment
Period.
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Federal Register:
General and Plastic
Surgery Devices;
Reclassification of
the Absorbable
Hemostatic Device;
Reopening of Comment
Period.
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General Hospital and
Personal Use Devices
Panel Advisory
Meeting, May 4, 2007
- Brief Summary
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Guidance for
Industry and FDA
Staff - Class II
Special Controls
Guidance Document:
Class II Special
Controls Guidance
Document: Gene
Expression Profiling
Test System for
Breast Cancer
Prognosis
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May
7, 2007 |
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510(k) Final
Decisions - April
2007
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Consumer Information
on: Onyx Liquid
Embolic System (Onyx
HD-500) - H060003
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Medical Device Links
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Industry
Assistance
Health
Topics
About
CDRH
Device
Program Areas
Radiological
Health
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Weekly CFR Rule Changes
529 -
510 - 866
Spotlight Guidance:
Computerized systems used in
clinical investigations |
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Friday,
May 11, 2007 |
NONE
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Thursday,
May 10, 2007 |
NOTICES
Meetings:
Medical Devices Advisory
Committee,
26637 [E7–9054]
[TEXT] [PDF]
Vaccines and Related
Biological Products Advisory
Committee; correction,
26637–26638 [E7–9053]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Computerized systems used in
clinical investigations;
industry guidance,
26638–26639 [E7–9056]
[TEXT] [PDF]
Protecting rights, safety,
and welfare of study
subjects; supervisory
responsibilities of
investigators; industry
guidance,
26639 [E7–9055]
[TEXT] [PDF]
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Wednesday,
May 9, 2007 |
RULES
Animal drugs, feeds, and
related products:
Oxytetracycline,
26289 [E7–8869]
[TEXT] [PDF]
Sponsor name and address
changes—
Abraxis Pharmaceutical
Products,
26288–26289 [E7–8870]
[TEXT] [PDF]
Medical
devices:
Immunology and microbiology devices—
Gene expression profiling
test system for breast
cancer prognosis;
classification,
26290–26291 [E7–8871]
[TEXT] [PDF]
NOTICES
Reports and
guidance documents;
availability, etc.:
Gene expression profiling
test system for breast
cancer prognosis; class II
special controls,
26398–26399 [E7–8872]
[TEXT] [PDF]
Type C medicated feeds;
analytical methods
description; industry
guidance,
26399 [E7–8808]
[TEXT] [PDF]
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Tuesday,
May 8, 2007 |
PROPOSED RULES
Medical devices:
General and plastic surgery devices—
Absorbable hemostatic device; reclassification,
26011 [E7–8784]
[TEXT] [PDF]
NOTICES
Agency
information collection
activities;
proposals, submissions, and
approvals,
26132–26134 [E7–8783]
[TEXT] [PDF]
Reports and guidance
documents; availability,
etc.:
Absorbable hemostatic device; Class II special
controls,
26134–26135 [E7–8780]
[TEXT] [PDF]
Medicated feed manufacturing facilities; voluntary self
inspection; compliance
policy guide,
26135 [E7–8781]
[TEXT] [PDF]
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Monday,
May 7, 2007 |
NOTICES
Meetings:
Oncologic
Drugs Advisory Committee,
25767–25768 [E7–8656]
[TEXT] [PDF]
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US GMP Training Booklet
US GLP Trainer Booklet
US GCP Trainer Booklet |
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Standard-GMPs
Parts
11, 210, 211, 820 & ICH Q7A |
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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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