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 |
August 17,
2007
- FDA issues an
FDA Alert, Public Health
Advisory, and Information for
Healthcare Professional sheet on
the use of codeine products in
nursing mothers.
Drug Information
- FDA approves
updated warfarin (marketed as
Coumadin) prescribing
information.
FDA News
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New and Generic
Drug Approvals
-
Hydrocodone
Bitartrate and Acetaminophen
Tablets, Ranbaxy Labs, Approval
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Simvastatin
Tablets, Dr. Reddy’s Labs,
Approval
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Tegretol
(carbamazepine) Tablets,
Novartis Pharma, Labeling
Revision
-
Tegretol
(carbamazepine) Chewable
Tablets, Novartis Pharma,
Labeling Revision
-
Tegretol
(carbamazepine) Suspension,
Novartis Pharma, Labeling
Revision
-
Tegretol
(carbamazepine) Extended-Release
Tablets, Novartis Pharma,
Labeling Revision
-
Viramune
(nevirapine) Tablets, Boehringer
Ingelheim, Labeling Revision
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Viramune
(nevirapine) Oral Suspension,
Boehringer Ingelheim, Labeling
Revision
-
Zingo
(lidocaine hydrochloride
monohydrate) Powder, Anesiva
Inc., Approval
August 16,
2007
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New and Generic
Drug Approvals
-
Actos
(pioglitazone HCl) Tablets,
Takeda Global, Labeling Revision
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Avandia
(rosiglitazone maleate) Tablets,
SB Pharmco, Labeling Revision
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Coumadin
(warfarin sodium) Tablets and
Injection, Bristol Myers,
Labeling Revison
-
Octreotide
Acetate Injection, Sun Pharma,
Approval
-
Ranitidine
Oral Solution, Actavis
Elizabeth, Tentative Approval
-
Renagel
(sevelamer hydrochloride)
Tablets, Genzyme Corp., Labeling
Revision
August 15,
2007
August 14,
2007
-
Drugs@FDA
Downloadable Data Files
(updated)
- Abbott
Laboratories sends a Dear
Healthcare Provider Letter to
physicians and pharmacists that
prescribe or distribute Kaletra
Oral Solution.
MedWatch Safety Information
- FDA announces
that manufacturers of some
diabetes drugs have strengthened
the warning on heart failure
risk.
FDA News
-
New and Generic
Drug Approvals
-
Amoxicillin
and Clavulanate Potassium Oral
Suspension, Lek Pharma, Approval
-
Astelin
(azelastine hydrochloride) Nasal
Spray, Medpointe Pharma,
Labeling Revision
-
Elidel
(pimecrolimus) Cream, Novartis
Pharma, Labeling Revision
-
Fenofibrate
Tablets, LifeCycle Pharma,
Approval
-
Genotropin
(somatropin [rDNA origin])
Injection, Pharmacia & Upjohn,
Control Supplement
-
Lamivudine/Stavudine/
/Nevirapine Dispersible Tablets,
Cipla Ltd., Tentative Approval
-
Marplan
(isocarboxazid) Tablets, Validus
Pharma, Labeling Revision
-
Nevirapine
Tablets, Hetero Drugs, Tentative
Approval
-
Ondansetron
Orally Disintegrating Tablets,
Sandoz Inc., Approval
-
Proquin XR
(ciprofloxacin hydrochloride)
Extended-Release Tablets,
Depomed Inc., Labeling Revision
-
Ramipril
Capsules, Dr. Reddy’s Labs,
Tentative Approval
-
Tamsulosin
Capsules, Zydus Pharma,
Tentative Approval
- Warning
Letter:
Exelon (rivastigmine tartrate)
Capsules and Oral Solution,
Novartis Pharmaceuticals
Corporation
August 13,
2007
-
New and Generic
Drug Approvals
-
Cefotetan
Injection, Abraxis Pharma,
Approval
-
Cefotetan
Disodium Injection, B. Braun
Medical, Approval
-
ChloraPrep
(chlorhexidine gluconate)
Topical Solution, Enturia Inc.,
Control Supplement
-
Epirubicin
Hydrochloride Injection, Teva
Parenteral, Approval
-
Flunisolide
Nasal Solution, Apotex, Approval
-
Nalfon
(fenoprofen calcium) Capsules,
Pedinol Pharmacal, Labeling
Revision
-
Pentostatin
Injection, Bedford Labs,
Approval
-
Propranolol
Hydochloride, Extended-release
Capsules, Actavis, Approval
-
Repaglinide
Tablets, Caraco Pharma,
Tentative Approval
-
Ropinirole
Hydrochloride Tablets, Par
Pharma, Tentative Approval
-
Selzentry
(maraviroc) Tablets, Pfizer
Inc., Approval
-
Sildenafil
Citrate Tablets, Teva Pharma,
Tentative Approval
-
Tekturna
(aliskiren) Tablets, Novartis
Pharma, Labeling Revision
-
Verapamil
Hydrochloride Extended-release
Capsules, Mylan Pharma, Approval
- Notice of
Violation Letter:
Geodon (ziprasidone mesylate)
for Injection, Pfizer Inc.
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August 17, 2007 |
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Class
II Medical Device
Recall: Sunrise
Medical Quickie
Power Wheelchairs |
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August 16, 2007 |
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Federal Register:
Processing Methods
for Orthopedic,
Cardiovascular, and
Skin Allografts;
Public Workshop.
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August 14, 2007 |
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Federal Register:
Clinical Development
Programs for Human
Drugs, Biological
Products, and
Medical Devices for
the Treatment and
Prevention of
Osteoarthritis;
Request for
Assistance.
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Guidance for
Industry and FDA
Staff - Review
Criteria for
Assessment of
Qualitative Fecal
Occult Blood In
Vitro Diagnostic
Devices
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Orthopaedic and
Rehabilitation
Devices Panel
Advisory Meeting,
July 17, 2007 -
Transcripts
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August 13, 2007 |
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FDA
Preliminary Public
Health Notification
- Repair, Service,
or Testing May Not
Have Been Performed
on Certain Baxter
COLLEAGUE and
FLO-GARD Infusion
Pumps
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Consumer Information
on: VISX STAR S4 IR
Excimer Laser System
with Variable Spot
Scanning (VSS) and
WaveScan WaveFront
System - P930016S025
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CFR Rule Changes
this week -
74 -
700
- 606
- 607
- 610
- 640 - |
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Friday,
August 17, 2007 |
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NONE
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Thursday,
August 16, 2007 |
RULES
Biological
products:
Blood, blood components, and
source plasma; requirements,
45883–45888 [E7–15943]
[TEXT] [PDF]
PROPOSED RULES
Biological
products:
Blood, blood components, and
source plasma; requirements,
45993–45997 [E7–15942]
[TEXT] [PDF]
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
46087–46089 [E7–16087]
[TEXT] [PDF]
46089–46090 [E7–16088]
[TEXT] [PDF]
Meetings:
Nonprescription Drugs and
Pediatric Advisory
Committees,
46091–46092 [E7–16169]
[TEXT] [PDF]
Orthopedic, cardiovascular,
and skin allografts;
processing methods;
workshop,
46092 [E7–16182]
[TEXT] [PDF]
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Wednesday,
August 15, 2007 |
RULES
Cosmetics:
Human food and cosmetics
manufactured from, processed
with, or otherwise
containing material from
cattle; recordkeeping
requirements; CFR
correction,
45636 [07–55510]
[TEXT] [PDF]
NOTICES
Agency
information collection
activities;
proposals,
submissions, and approvals,
45819–45820 [E7–15939]
[TEXT] [PDF]
Meetings:
Women's health information
sharing network; workshop,
45820 [E7–15944]
[TEXT] [PDF]
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Tuesday,
August 14, 2007 |
RULES
Color additives:
D&C Black (No. 3),
45328–45329 [E7–15831]
[TEXT] [PDF]
NOTICES
Human drugs:
Drug products withdrawn from
sale for reasons other than
safety or effectiveness—
ORUDIS KT (ketoprofen)
tablets,
45434–45435 [E7–15843]
[TEXT] [PDF]
Human drugs,
biological products, and
medical devices:
Osteoarthritis treatment and
prevention; clinical
development programs,
45433–45434 [E7–15844]
[TEXT] [PDF]
Meetings:
Cardiovascular and Renal
Drugs Advisory Committee,
45435–45436 [E7–15834]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Exports under FDA Export
Reform and Enhancement Act;
industry guidance,
45436 [E7–15840]
[TEXT] [PDF]
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Monday,
August 13, 2007 |
RULES
Animal drugs, feeds, and
related products:
Ampicillin sodium,
45158–45159 [E7–15761]
[TEXT] [PDF]
Formalin,
45157–45158 [E7–15763]
[TEXT] [PDF]
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
45249–45250 [E7–15740]
[TEXT] [PDF]
Meetings:
Harmonization International
Conference—
Yokohama, Japan;
preparation,
45250 [E7–15803]
[TEXT] [PDF]
International Conference on
Cosmetics Regulations—
Brussels, Belgium;
preparation,
45250–45251 [07–3954]
[TEXT] [PDF]
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ICH
Q10 Step 3
US GMP Training Booklet
US GLP Trainer Booklet
US GCP Trainer Booklet
Combination Product handbook |
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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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