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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 |
|
CDER Links |
CBER Links |
CDRH Links |
June 22, 2007
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FDA News: FDA
approves Lyrica (pregabalin),
the first drug to treat
fibromyalgia, a disorder
characterized by pain, fatigue
and sleep problems.
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New and Generic
Drug Approvals
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Combunox
(oxycodone HCL and
Ibuprofen) Tablets, Forest
Labs, Labeling Revision
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Exforge
(amlodipine and valsartan)
Tablets, Novartis Pharma,
Approval
-
Floxin
(ofloxacin) Tablets, Ortho
McNeil Pharma, Labeling
Revision
-
Levaquin
(levofloxacin) Tablets,
Ortho-McNeil Pharma,
Labeling Revision
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Levaquin
(levofloxacin) Injection,
Ortho-McNeil Pharma,
Labeling Revision
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Levaquin
(levofloxacin) Oral
Solution, Ortho-McNeil
Pharma, Labeling Revision
-
Lithium
Carbonate Extended-Release
Tablets, Westward Pharma,
Control Supplement
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Loperamide
Hydrochloride/Simethicone
Chewable Tablets, Perrigo
Co., Facility Addition &
Control Supplement
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Plaquenil
(hydroxychloroquine sulfate,
USP) Tablets, Sanofi
Aventis, Labeling Revision
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Quinapril
Hydrochloride and
Hydrochlorothiazide Tablets,
Aurobindo Pharma, Tentative
Approval
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Tamsulosin
Hydrochloride Capsules,
Ranbaxy Labs, Tentative
Approval
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Trihexyphenidyl
Hydrochloride Tablets,
Watson Labs, Manufacturing
Revision
- Office of
Nonprescription Drugs:
Chronological List of All NDAC
Meetings (1992 to Present)
- Pediatric
Exclusivity Statistics:
Pediatric Exclusivity Labeling
Changes (updated)
June 21,
2007
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New and Generic
Drug Approvals
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Amoxicillin
Oral Suspension, Teva Pharma,
Control Supplement
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Copegus
(ribavirin) Tablets,
Hoffmann-La Roche, Labeling
Revision
-
Differin
(adapalene) Gel, Galderma
Labs, Approval
-
Diphenoxylate
HCL & Atropine Sulfate
Tablets, Ivax Pharma,
Facility Addition
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Dopamine
Hydrochloride in/Dextrose
Injection, Baxter
Healthcare, Labeling
Revision
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Flurbiprofen
Tablets, Caraco Pharma,
Labeling
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Ketorolac
Tromethamine Tablets, Teva
Pharma, Labeling
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Levodopa
Tablets, Actavis, Control
Supplement
-
Meclizine
HCL Tablets, Sandoz Inc.,
Control Supplement
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Meloxicam
Tablets, Caraco Pharma Labs,
Labeling
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Meloxicam
Tablets, Teva Pharma,
Labeling
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Mesalamine
Rectal Suspension, Perrigo
Co., Control Supplement
-
Nicotine
Polacrilex Gum(4mg),
Novartis, Approval
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Nicotine
Polacrilex Gum(2mg),
Novartis, Approval
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Ondansetron
Hydrochloride Injection,
Apotex Inc., Manufacturing
Revision
-
Oxaprozin
Tablets, Caraco Pharma,
Labeling
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Trileptal
(oxcarbazepine) Tablets,
Novartis, Labeling Revision
June 20,
2007
-
Dissolution
Methods for Drug Products
-
Drugs@FDA
Downloadable Data Files
(updated)
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New and Generic
Drug Approvals
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Desogestrel/Ethinyl
Estradiol and Ethinyl
Estradiol Tablets, Watson
Labs, Tentative Approval
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Letairis
(ambrisentan) Tablets,
Gilead Sciences, Approval
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Nuvigil
(armodafinil) Tablets,
Cephalon Inc., Approval
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OMNICEF
(cefdinir) Capsules, Abbott
Labs, Labeling Revision
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OMNICEF
Oral Suspension, Abbott
Labs, Labeling Revision
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Implementation of
Risk Minimization Action Plans (RiskMAPs)
to Support Quality Use of
Pharmaceuticals: Opportunities
and Challenges
(updated)
June 18,
2007
- On June 15,
FDA approved Letairis (ambrisentan)
for the treatment of pulmonary
arterial hypertension.
FDA News
-
Drug Approval
Reports
-
New and Generic
Drug Approvals
-
Adenosine
Injection, Gland Pharma,
Approval
-
Cefprozil
Tablets, Wockhardt, Approval
-
Digoxin
Tablets, Caraco Pharma,
Control Supplement
-
Humalog
(insulin lispro injection [rDNA
origin]) Injection, Eli
Lilly, Labeling Revision
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Hydroxychloroquine
Sulfate Tablets, Ipca Labs,
Approval
-
Isosorbide
Mononitrate Extended-release
Tablets, KV Pharma, Package
Addition
-
Lexiva
(fosamprenavir calcium) Oral
Suspension, GlaxoSmithKline
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Omeprazole
Delayed-Release Tablets,
Dexcel Pharma, Tentative
Approval
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Ondansetron
Injection, Apotex,
Manufacturing Revision
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Prevacid
(lansoprazole)
Delayed-Release Capsules,
TAP Pharma, Labeling
Revision
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Prevacid
(lansoprazole)
Delayed-Release Suspension,
TAP Pharma, Labeling
Revision
-
Prevacid
(lansoprazole)
Delayed-Release Orally
Disentegrating Tablets, TAP
Pharma, Labeling Revision
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Terbinafine
Hydrochloride Tablets,
Glenmark Pharma, Tentative
Approval
- BPCA/Pediatric
Exclusivity Statistics:
Pediatric Exclusivity Statistics
(updated)
- Office of
Nonprescription Products:
Rulemaking History for
Nonprescription Products
(updated)
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June
21, 2007 |
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FDA
Clears 'Computerized
Medication Box' for
U.S. Market
 |
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June
19, 2007 |
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Guidance for
Industry and FDA
Staff: Performance
Standard for
Diagnostic X-Ray
Systems and Their
Major Components;
(21CFR 1020.30,
1020.31, 1020.32,
1020.33); Small
Entity Compliance
Guide
 |
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Federal Register:
Guidance for
Industry and Food
and Drug
Administration
Staff;
Pharmacogenetic
Tests and Genetic
Tests for Heritable
Markers;
Availability
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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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CFR Rule Changes
This Week -
558 -
74 -
1271 |
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Friday,
June 22, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
34470–34471 [E7–12056]
[TEXT] [PDF]
34471 [E7–12057]
[TEXT] [PDF]
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Thursday,
June 21, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
34255–34256 [E7–11969]
[TEXT] [PDF]
34256–34257 [E7–11980]
[TEXT] [PDF]
34257–34259 [E7–11981]
[TEXT] [PDF]
Reports and guidance
documents; availability,
etc.:
Electronic based testing for compatibility between
donor's cell type and
recipient's serum or plasma
type; computer crossmatch,
34259–34260 [E7–11998]
[TEXT] [PDF]
Source plasma donors participating in plasmapheresis
and immunization programs;
informed consent
recommendations,
34260 [E7–11997]
[TEXT] [PDF]
Veterinary Medicinal Products, International
Cooperation on Harmonisation
of Technical Requirements
for Approval—
Pharmacovigilance veterinary
medicinal products;
controlled list of terms,
34261–34262 [E7–11996]
[TEXT] [PDF]
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Wednesday,
June 20, 2007 |
NONE
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Tuesday,
June 19, 2007 |
RULES
Color additives:
D&C Black No. 3,
33664–33667 [E7–11801]
[TEXT] [PDF]
Human cells, tissues, and
cellular and tissue-based
products; donor screening
and testing, and related
labeling,
33667–33669 [E7–11795]
[TEXT] [PDF]
NOTICES
Meetings:
Cellular, Tissue, and Gene
Therapies Advisory
Committee,
33764 [E7–11728]
[TEXT] [PDF]
Science Board; correction,
33765 [E7–11727]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Heritable markers;
pharmacogenetic and genetic
tests,
33765–33766 [E7–11817]
[TEXT] [PDF]
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Monday,
June 18, 2007 |
RULES
Animal drugs, feeds, and
related products:
Lincomycin,
33386–33387 [E7–11611]
[TEXT] [PDF]
NOTICES
Meetings:
Anthrax vaccines; bridging
correlates of protection in
amimals to immunogenicity in
humans; public workshop,
33508–33509 [E7–11613]
[TEXT] [PDF]
Apheresis blood products
licensure; public workshop,
33509 [E7–11615]
[TEXT] [PDF]
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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 |
|
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
|
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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