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GXPNews.com - FDA
News and Announcements
- May 14, 2007
- May 18, 2007 |
The once a week
newsletter reporting on what's new within the
Food and Drug Administration (FDA)
Distributed by the worlds
leader in Federal Regulations,
GMP Publications, Inc. &
FDA.COM
Send Comments to:
John Cuspilich, Sr. Editor, -
Newsletter
Archive
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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 |
May 18, 2007
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Attention-Deficit Hyperactivity
Disorder (ADHD) Medication
Guides
May 17,
2007
May 16,
2007
May 15,
2007
- Guidance for
Industry:
Clinical Trial
Endpoints for the Approval of
Cancer Drugs and Biologics [PDF]
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Guidance for
Industry: Labeling for Human
Prescription Drugs --
Determining Established
Pharmacologic Class for Use in
the Highlights of Prescribing
Information [PDF]
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Paragraph IV
Patent Certifications
(updated)
May 14,
2007
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Updated Package Insert: Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB ) - Merck & Co, Inc
Posted: 5/17/2007, Approval Date: 5/15/2007Vacancy Announcement - Consumer Safety Officer, DCM/OCBQ
Posted: 5/16/2007
FDA Approves Expanded Use for Surgical Sealant
Posted: 5/16/2007
Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
Posted: 5/15/2007
Premarket Approval: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L - Roche Molecular Systems, Inc
Posted: 5/14/2007, Approval Date: 5/11/2007
Premarket Approval: Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit - ABBOTT Molecular, Inc
Posted: 5/14/2007, Approval Date: 5/11/2007
Vacancy Announcement - Consumer Safety Officer, DCCA/OCTMA
Posted: 5/14/2007
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May
18, 2007 |
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FDA
Preliminary Public
Health Notification:
Possible
Contamination and
Malfunction of Heart
Valves and Valve
Conduits,
Annuloplasty Rings,
Surgical Grafts,
Meshes and Other
Devices Manufactured
by Shelhigh, Inc.
(Updated 5/18)
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May
16, 2007 |
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Orthopaedic and
Rehabilitation
Devices Panel
Advisory Meeting,
February 22, 2007 -
Minutes
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Product Codes for
Radiation-Emitting
Electronic Products
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May
15, 2007 |
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Consumer Information
on: IMMULITE/IMMULITE
1000 and IMMULITE
2000 Free PSA -
P060005
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PMA
Final Decisions for
April 2007
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May
14, 2007 |
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Medical Devices
Dispute Resolution
Panel Advisory
Meeting, April 19,
2007 - Transcripts
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Orthopaedic and
Rehabilitation
Devices Panel
Advisory Meeting,
April 24, 2007 -
Transcripts
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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
522 - 510
- 520 - 510 -
522 -
520 |
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Friday,
May 11, 2007 |
RULES
Animal drugs, feeds, and
related products:
Butorphanol tartrate injection,
2795627957 [E79557]
[TEXT] [PDF]
Phenylbutazone power; oral dosage
form,
2795527956 [E79559]
[TEXT] [PDF]
Sponsor name and address changes
Modern Veterinary Therapeutics, L.LC,
27955 [E79555]
[TEXT] [PDF]
NOTICES
Reports and guidance
documents; availability,
etc.:
Target animal safety for veterinary pharmaceutical
products, VICH GL43,
2805828059 [E79592]
[TEXT] [PDF]
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Thursday,
May 10, 2007 |
RULES
Animal drugs, feeds, and
related products:
Ivermectin; implantation or
injectable dosage form,
2773427735 [E79515]
[TEXT] [PDF]
Ivermectin and clorsulon;
implantation or injectable
dosage form,
2773327734 [E79517]
[TEXT] [PDF]
Pimobendan; oral dosage
form,
27733 [E79516]
[TEXT] [PDF]
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Wednesday,
May 9, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
2757327574 [E79435]
[TEXT] [PDF]
2757427575 [E79436]
[TEXT] [PDF]
Human drugs:
Drug products withdrawn from
sale for reasons other than
safety or effectiveness
MEPRON (atovaquone) tablets,
250 milligrams,
27575 [E79348]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Clinical trial endpoints for
approval of cancer drugs and
biologics; industry
guidance,
2757527576 [E79345]
[TEXT] [PDF]
Labeling for human
prescription drugs;
determining established
pharmacologic class for use
in highlights of prescribing
information,
2757627577 [E79347]
[TEXT] [PDF]
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Tuesday,
May 8, 2007 |
NONE
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Monday,
May 7, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
2713527138 [E79219]
[TEXT] [PDF]
2713827140 [E79220]
[TEXT] [PDF]
2714027142 [E79221]
[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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The e-Newsletter of
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GMP Publications, Inc. & FDA.COM
Tel: 866-GXPNews (or 856-810-7331) Fax: 856-810-7339
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