|
Center
for Drug Evaluation &
Research (CDER) News |
Center
for Biologics Evaluation &
Research (CBER) |
Center
for Device &
Radiological
Health (CDRH) |
Federal Register -
Meetings, Notices, & Rule Changes |
November 28, 2008
-
Guidance for Industry:
Submission of Patent Information
for Certain Old Antibiotics [PDF]
-
New
and Generic Drug Approvals
-
A-MethaPred
(Methylprednisolone Sodium
Succinate) Injection,
Hemopharm USA Corporation,
Approval
-
Acetaminophen, Caffeine, and
Dihydrocodeine Bitartrate
Capsules, e5 Pharma, LLC.,
Control Supplement
-
Aldactone
(spironolactone) Tablets,
Pfizer Global
Pharmaceuticals, Labeling
Revision
-
Aleve
(naproxen sodium) Tablets,
Bayer HealthCare LLC,
Labeling Revision
-
Amoxicillin and Clavulanate
Potassium
Oral Suspension, Morton
Grove Pharmaceuticals, Inc.,
Approval
-
Budesonide
Inhalation Suspension, IVAX
Pharmaceuticals, UK,
Approval
-
Divalproex Sodium
Delayed-release Tablets,
Orchid Healthcare, Approval
-
Famotidine
Tablets, L. Perrigo Co.,
Control Supplement
-
Flumadine
(rimantadine hydrochloride)
Tablets, Forest
Laboratories, Inc., Labeling
Revision
-
Irinotecan Hydrochloride
Injection, Accord Healthcare
Inc., USA, Approval
-
Lactulose
Oral or Rectal Solution, ANI
Pharmaceuticals, Inc.,
Approval
-
Metformin Hydrochloride
Tablets, Indicus Pharma LLC,
Approval
-
Methylergonovine Maleate
Injection, PharmaForce,
Inc., Approval
-
MoviPrep
(PEG-3350, sodium sulfate,
sodium chloride, potassium
chloride, sodium ascorbate,
and ascorbic acid) Oral
Solution, Salix
Pharmaceuticals, Inc.,
Labeling Revision
-
Ofloxacin
Ophthalmic Solution, Sandoz
Inc., Approval
-
Olanzapine
Tablets, Roxane Labs,
Tentative Approval
-
Selzentry
(maraviroc) Tablets, Pfizer
Inc., Accelerated Approval
-
Sucraid
(sacrosidase) Oral Solution,
QOL Medical, Manufacturing
Change or Addition
-
Tapentadol
Tablets, Johnson & Johnson
Pharmaceutical Research
& Development, L.L.C.,
Approval
-
Viracept
(nelfinavir mesylate) 625 mg
Tablets, Pfizer Inc.,
Labeling Revision
-
Viracept
(nelfinavir mesylate) 250 mg
Tablets, Pfizer Inc.,
Labeling Revision
-
Viracept
(nelfinavir mesylate) Oral
Powder, Pfizer Inc.,
Labeling Revision
-
Zolpidem Tartrate
Tablets, Vintage
Pharmaceuticals, LLC
Approval
-
Zaleplon
Capsules, West-ward
Pharmaceutical Corp.,
Approval
-
Zyrtec
(cetirizine hydrochloride)
Tablets, McNeil Consumer
Healthcare, Manufacturing
Change or Additio
November 26, 2008
November 25, 2008
CDER
Drug Links
|
|
|
November 26, 2008 |
 |
Summary Information
for: BIOFINITY (comfilcon
A) Soft Contact Lens
for Extended Wear
 |
|
|
Summary Information
for: Carotid
WALLSTENT Monorail
Endoprosthesis
|
|
|
Consumer Information
on: COBAS TaqMan HCV
Test For Use With
the COBAS AmpliPrep
Instrument and the
COBAS TaqMan
Analyzer or the
COBAS TaqMan 48
Analyzer - P060030
 |
|
|
FDA/AdvaMed
Workshop: Gender
Differences in
Cardiovascular
Device Trials,
December 9, 2008
|
|
|
Summary Information
for: Helios II
Ablation Catheter
|
|
|
Federal Register:
Sex Differences in
the Cardiovascular
Device Trials;
Public Workshop
|
|
|
|
November 25, 2008 |
|
|
PMA Final Decisions
for October 2008
|
|
|
|
Medical Device Links
|
|
This
Week
Rule Changes:
21 CFR Parts
530 |
|
Friday,
Nov. 28, 2008 |
NOTICES
Meetings:
Pediatric Ethics Subcommittee; Amendment,
7249372494 [E828382]
[TEXT] [PDF]
|
|
Thurs.,
Nov. 27, 2008 |
NONE
|
|
Wed., Nov.
26, 2008 |
RULES
New Animal Drugs;
Cephalosporin Drugs;
Extralabel Animal Drug Use;
Revocation of Order of
Prohibition; Withdrawal,
71923 [E828093]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals,
7205572058 [E828064]
[TEXT] [PDF]
7205872062 [E828065]
[TEXT] [PDF]
Draft Guidance for Industry;
Availability
Small Entities Compliance
Guide for Renderers;
Substances Prohibited From
Use in Animal Food or Feed,
7206272063 [E828189]
[TEXT] [PDF]
Sex Differences in the
Cardiovascular Device
Trials; Public Workshop,
7206372064 [E828169]
[TEXT] [PDF]
|
|
Tuesday,
Nov. 25, 2008 |
NOTICES
Compliance Policy Guide Sec.
540.700 Processed and/or
Blended Seafood Products (CPG
7108.16); Availability,
71655 [E827969]
[TEXT] [PDF]
|
|
Monday,
Nov. 24, 2008 |
|
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Mental Models Study of Health Care Providers
Understanding of
Prescription Drug
Effectiveness,
7100671007 [E827801]
[TEXT] [PDF]
Debarment Orders:
George Kindness,
7100771008 [E827802]
[TEXT] [PDF]
Roy Page, M.D.,
7100871009 [E827803]
[TEXT] [PDF]
Draft Guidance for Industry
on the Contents of a
Complete Submission for the
Evaluation of Proprietary
Names; Availability,
7100971010 [E827896]
[TEXT] [PDF]
|
|
|
|
.jpg)
EU - US - ICH GMP
Combination Product
handbook |
|
US GMP Training Booklet |
|
Std. GMPs
- Parts 11, 210, 211, 820 &
ICH Q7 |
|
Med. Device - 11, 50,
54, 56, 807, 812, 814, 820,
510k/PMA |
|
Clinical GCP - Parts 11,
50, 54, 56, 312, 314 & ICH
E2A & E6 |
|
Multi-US GMPs 11, 58,
210/211, 600, 601, 610
& 820 |
|
Parts 210/211 - Drug
GMPs |
|
>210/211
with Part 11 |
|
>210/211
with Part 820 |
|
>210/211
with Parts 820 & 11 |
|
>210/211
w/ Keyword Index |
Part 820
Quality Systems Regs
|
|
Part 58 - GLP Good
Lab. Practice |
Part 11
- Electronic Records w/
Scope and Applications
|
GLP 2 11 & 58 - Part 11
& 58
|
PDMA 11,
203 & 205 - Prescription
Drug Marketing
|
|
|
11
& 820 Electronic Record
and Quality Systems
|
|
|
|
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