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 |
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CDER Links |
CBER Links |
CDRH Links |
March 30,
2007
- Novartis
Pharmaceuticals has agreed to
FDA’s request that they
voluntarily discontinue
marketing and sales of Zelnorm (tegaserod
maleate).
Zelnorm information
- New Patient
Information Sheet for
Invega (paliperidone)
- Office of
Generic Drugs:
FDA solicits
comments on Amlodipine
Abbreviated New Drug Application
Approval issues
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Paragraph IV
Patent Certifications
(updated)
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New and Generic
Drug Approvals
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Albuterol
Sulfate & Ipratropium
Bromide Injection, Breath
Ltd., Tentative Approval
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BARACLUDE
(entecavir) Tablets,
Bristol-Myers Squibb, New
Dosage Regimen
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BARACLUDE
(entecavir) Oral Solution,
Bristol-Myers Squibb, New
Dosage Regimen
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Citalopram
Hydrobormide Tablets,
Torrent Pharma, Approval
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Finasteride
Tablets, Actavis, Approval
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Hydrochlorothiazide
Tablets, Caraco Pharma,
Approval
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Irbesartan
Tabelts, Teva Pharma,
Tentative Approval
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Ondansetron
Hydrochloride Tablets,
Sandoz Inc., Tentative
Approval
March 29,
2007
March 28,
2007
March 27,
2007
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The Adverse Event
Reporting System (AERS) Latest
Quarterly Data Files
-
Cyber Letters
(updated)
- "Dear
Healthcare Professional Letter"
for Ketek (telithromycin) issued
by Sanofi-aventis.
MedWatch
Information
- International
Conference on Harmonization (ICH)
Public Meeting Friday, April 6,
2007, Rockville, MD.
Meeting Information
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New and Generic
Drug Approvals
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Amoxicillin
Oral Suspension, Sandoz
Inc., Approval
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Ceftriaxone
Injection, Cephazone Pharma,
Approval
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Ciclopirox
Topical Solution, Taro
Pharma, Tentative Approval
-
Ciprofloxacin
Extended-Release Tablets,
Dr. Reddy’s Labs, Approval
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Cyclessa
(desogestrel/ethinyl
estradiol) Tablets, Organon
Inc., Labeling Revision
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Efavirenz
Tablets, Strides Inc.,
Tentative Approval
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Gemfibrozil
Tablets, Perrigo R& D Co.,
Approval
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Ondansetron
Injection, Spectrum Pharma,
Approval
March 26,
2007
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New and Generic
Drug Approvals
-
Aldara
(imiquimod) Cream, Graceway
Pharma, Efficacy Supp.
w/Clinical Data
-
Amlodipine
Besylate Tablets, Gedeon
Richter, Tentative Approval
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Ciprofloxacin
Extended-release Tablets,
Mylan Pharma, Approval
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Furosemide
Injection, Wockhardt Ltd,
Approval
-
Loratadine
Tablets, Ranbaxy Labs,
Control Supplement
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Oxandrolone
Tablets, Upsher-Smith Labs,
Approval
-
Primaxin
I.M. Injectable Suspension (Imipenem
and Cilastatin), Merck &
Co., Labeling Revision
-
Reyataz
(atazanavir) capsules,
Bristol-Myers Squibb,
Labeling Revision
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March
29, 2007 |
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Clinical Chemistry
and Clinical
Toxicology Devices
Panel Advisory
Meeting, December 6,
2006 - Minutes
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Medical Device
Safety Article:
Prevent Dangerous
Hemodialysis
Catheter
Disconnections
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March
28, 2007 |
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Federal Register:
Determination of
Regulatory Review
Period for Purposes
of Patent Extension;
INFUSE BONE
GRAFT/LT-CAGE LUMBAR
TAPERED FUSION
DEVICE.
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March
27, 2007 |
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Approval of
Alternate Means of
Labeling for Laser
Products (Laser
Notice 53) -
Guidance for
Industry and FDA
Staff
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Consumer Information
on Breast Pumps
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Federal Register:
Draft Guidance for
Industry and Food
and Drug
Administration
Staff; Modifications
to Devices Subject
to Premarket
Approval--The
Premarket Approval
Supplement
Decision-Making
Process;
Availability.
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Summary Information
for: MESOMARK
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Consumer Information
on: MESOMARK -
H060004
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Class
I Medical Device
Recall: Smith &
Nephew, Inc.
Radiofrequency
Denervation Probes
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March
26, 2007 |
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11th
Conference of the
Global Harmonization
Task Force (2007):
General Announcement
and Booking
Information
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Summary Information
for: Guardian
REAL-Time and
Paradigm REAL-Time
Systems
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Federal Register:
Orthopaedic and
Rehabilitation
Devices Panel of the
Medical Devices
Advisory Committee;
Notice of Meeting.
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Summary Information
for: Stelkast
Surpass Acetabular
System
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Summary Information
for: Therapy Cool
Path Ablation
Catheter and IBI
1500T9 RF Ablation
Generator
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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 -
310
-
201/310 |
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Friday,
March 30, 2007 |
RULES
Human
drugs:
Prescription-dispensing
requirements; new drugs
exemptions; technical
amendment,
15043 [E7–5895]
[TEXT] [PDF]
PROPOSED
RULES
Human
and animal drugs:
Cattle
material; prohibited use in
medical products for humans
and drugs intended for use
in ruminants,
15080–15081 [E7–5894]
[TEXT] [PDF]
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
15140–15141 [07–1577]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Target product profile;
strategic development
process tool,
15141–15142 [E7–5949]
[TEXT] [PDF]
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Thursday,
March 29, 2007 |
RULES
Human drugs:
Laxative
products (OTC)—
Psyllium ingredients in
granular dosage forms,
14669–14674 [E7–5740]
[TEXT] [PDF]
NOTICES
Biological
products:
Patent extension; regulatory
review period
determinations—
RETEVASE,
14818–14819 [E7–5736]
[TEXT] [PDF]
Human drugs:
Patent extension; regulatory
review period
determinations—
VAPRISOL,
14819–14820 [E7–5737]
[TEXT] [PDF]
Meetings:
Feed contaminants; animal and
human health; ranking
method,
14820–14821 [E7–5820]
[TEXT] [PDF]
Women's Health Information
Sharing Network; workshop,
14822 [07–1546]
[TEXT] [PDF]
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Wednesday,
March 28, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
14581–14582 [E7–5634]
[TEXT] [PDF]
Medical
devices:
Patent extension; regulatory
review period
determinations—
Infuse Bone Graft/LT-Cage
Lumbar Tapered Fusion
Device,
14582–14583 [E7–5635]
[TEXT] [PDF]
Meetings:
FDA clinical trial
requirements; public
workshop,
14583–14584 [E7–5633]
[TEXT] [PDF]
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Tuesday,
March 27, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
14279–14280 [E7–5505]
[TEXT] [PDF]
Human drugs:
Patent extension; regulatory
review period
determinations—
A180
14280–14281 [E7–5504]
[TEXT] [PDF]
Meetings:
Endocrinologic and Metabolic
Drugs Advisory Committee,
14281–14282 [E7–5506]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Modifications to devices
subject to premarket
approval; supplement
decision-making process,
14282–14283 [E7–5572]
[TEXT] [PDF]
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Monday,
March 26, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
14116–14118 [E7–5470]
[TEXT] [PDF]
Human drugs:
Drug products withdrawn from
sale for reasons other than
safety or effectiveness—
DURICEF (cefadroxil USP)
tablets, 1 gram, and
capsules, 500 milligrams,
14118 [E7–5415]
[TEXT] [PDF]
Patent extension; regulatory
review period
determinations—
EMTRIVA,
14122–14123 [E7–5446]
[TEXT] [PDF]
NOVOLOG,
14121–14122 [E7–5445]
[TEXT] [PDF]
ONYX LES,
14120–14121 [E7–5444]
[TEXT] [PDF]
PREVICOX,
14119–14120 [E7–5443]
[TEXT] [PDF]
REVLIMID,
14118–14119 [E7–5439]
[TEXT] [PDF]
Meetings:
Medical Devices Advisory
Committee,
14123 [E7–5469]
[TEXT] [PDF]
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US GMP Training Booklet
-
Parts 11 - Electronic Records
w/ "Scope &
Application"
- 58 Good Lab.
Practices
-
210/211 Drug GMPs
- 820 Quality Systems
- "GMPs for the 21st.
Century"
- "Quality Systems Approach
to GMPs" |
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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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