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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 |
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June 15, 2007
June 14,
2007
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Medication Guide
for Soliris (eculizumab)
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Drug Shortage;
Drug to be Discontinued;
Neutrexin (trimetrexate
glucuronate) Injection
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New and Generic
Drug Approvals
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Butalbital,
Aspirin, & Caffeine
Capsules, Mutual Pharma,
Approval
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Bupropion
Hydrochloride
Extended-Release Tablets
(300mg), Watson Labs,
Approval
-
Bupropion
Hydrochloride
Extended-Release Tablets
(150mg), Watson Labs,
Tentative Approval
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Cefpodoxime
Proxetil Tablets, Aurobindo
Pharma, Approval
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Extina
(ketoconazole) Foam, Stiefel
Labs, Approval
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Irbesartan
Tablets, Sandoz Inc.,
Tentative Approval
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Irbesartan
and Hydrochlorothiazide
Tablets, Sandoz Inc.,
Tentative Approval
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Lescol
(fluvastatin sodium)
Capsules, Novartis Pharma,
Labeling Revision
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Lescol XL
(fluvastatin sodium)
Extended-Release Tablets,
Novartis Pharma, Labeling
Revision
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Omacor
(omega-3-acid ethyl esters)
Capsules, Reliant Pharma,
Approval
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Terbinafine
Hydrochloride Tablets,
Orchid Healthcare, Tentative
Approval
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Trandolapril
Tablets, Cobalt Pharma,
Approval
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Trandolapril
Tablets, Aurobindo Pharma,
Approval
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Trandolapril
Tablets, InvaGen Pharma,
Approval
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Trandolapril
Tablets, Lupin Ltd.,
Approval
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Trandolapril
Tablets, CorePharma,
Approval
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Trandolapril
Tablets, Cipla Ltd.,
Approval
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Zerit
(stavudine) Capsules,
Bristol-Myers Squibb,
Labeling Revision
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Zerit
(stavudine) Powder for Oral
Solution, Bristol-Myers
Squibb, Labeling Revision
June 13,
2007
June 12,
2007
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Drug Shortage:
Current; Lymphazurin 1%
injection (isosulfan blue)
(updated)
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New and Generic
Drug Approvals
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Adderall
Tablets, Shire, Labeling
Revision
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Benzonatate
Capsules, Zydus Pharma,
Approval
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Betoptic
S (betaxolol hydrochloride)
Ophthalmic Suspension, Alcon
Research, Patient Population
Altered
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Cefpodoxime
Proxetil Oral Suspension,
Aurobindo Pharma, Approval
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Desogen
(desogestrel/ethinyl
estradiol) Tablets, Organon
Inc., Labeling Revision
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Diclofenac
Sodium Delayed-Release
Tablets, Unique Pharma,
Approval
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Doxycycline
Tablets, Mylan Pharma,
Approval
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Methylin
(methylphenidate
hydrochloride) Oral
Solution, Mallinckrodt,
Labeling Revision
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Methylin
(methylphenidate
hydrochloride) Chewable
Tablets, Mallinckrodt,
Labeling Revision
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Naproxen
Tablets, Zydus Pharma,
Approval
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Pataday
(olopatadine hydrochloride)
Ophthalmic Solution, Alcon
Research, Labeling Revision
& Package Change
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Timolol
GFS (timolol maleate)
Ophthalmic Gel Solution,
Falcon Pharma, Patient
Population Altered
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Implementation of
Risk Minimization Action Plans (RiskMAPs)
to Support Quality Use of
Pharmaceuticals: Opportunities
and Challenges
(updated)
June 11,
2007
- BPCA/Pediatric
Exclusivity Statistics:
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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 -
888 |
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Friday,
June 15, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
33231–33232 [E7–11527]
[TEXT] [PDF]
33232–33233 [E7–11528]
[TEXT] [PDF]
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Thursday,
June 14, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
32851–32852 [E7–11425]
[TEXT] [PDF]
Human drugs:
New drug applications—
Otsuka Pharmaceutical Co., Ltd.;
approval withdrawn,
32852 [E7–11427]
[TEXT] [PDF]
Meetings:
Oncologic Drugs Advisory
Committee,
32852–32853 [E7–11496]
[TEXT] [PDF]
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Wednesday,
June 13, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
32670–32672 [E7–11400]
[TEXT] [PDF]
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Tuesday,
June 12, 2007 |
RULES
Medical devices:
Orthopedic devices—
Intervertebral body fusion
device; reclassification,
32170–32172 [E7–11240]
[TEXT] [PDF]
NOTICES
Reports and guidance
documents; availability,
etc.:
Intervertebral body fusion
device; Class II special
controls,
32299–32300 [E7–11235]
[TEXT] [PDF]
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Monday,
June 11, 2007 |
PROPOSED RULES
Administrative rulings and
decisions:
Ozone-depleting substances
use; essential-use
designations—
Oral pressurized metered-dose
inhalers containing
flunisolide, triamcinolone,
metaproterenol, pirbuterol,
albuterol, etc.; removed,
32030–32049 [07–2883]
[TEXT] [PDF]
NOTICES
Committees; establishment,
renewal, termination, etc.:
Food Safety Public Advisory
Committee; nonvoting
industry representatives,
32123–32124 [E7–11141]
[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 |
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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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