|
 |
|
 |
|
Center for Drug Evaluation &
Research (CDER) News
Drug
Approvals -
Meetings
-
Links |
Center for Biologics Evaluation
& Research (CBER)
Meetings
-
Links |
Center for Device &
Radiological Health (CDRH)
Meetings
-
Links |
Federal Register - Meetings,
Notices, & Rule Changes |
|
CDER NEWS |
|
|
|
|
September
23, 2011
-
Aldactazide
(spironolactone
and
hydrochlorothiazide)
Tablets,
G.D.
Searle,
LLC,
Labeling
Revision
-
Aldactone
(spironolactone)
Tablets,
G.D.
Searle,
LLC,
Labeling
Revision
-
Arzerra
(ofatumumab)
Injection,
GlaxoSmithKline,
Supplement
-
Doxercalciferol
Injection,
Mylan
Institutional,
LLC,
Tentative
Approval
-
Glycopyrrolate
Injection,
Hikma
Farmaceutica,
Approval
-
Lamivudine
and
Zidovudine
Tablets,
Cipla
Limited,
Tentative
Approval
-
Reglan
(metoclopramide
hydrochloride)
Tablets,
ANI
Pharmaceuticals,
Inc.,
Labeling
Revision
-
Tricor
(fenofibrate)
Tablets,
Abbott
Laboratories,
Labeling
Revision
-
Viibryd
(vilazodone
hydrochloride)
Tablets,
Forest
Laboratories,
Inc.,
Labeling
Revision
-
Zolmitriptan
Tablets,
Glenmark
Generics
Limited,
Tentative
Approval
September
22, 2011
-
Detrol
(tolterodine
tartrate)
Tablets,
Pfizer
Global
Research
and
Development,
Labeling
Revision
-
Detrol
LA (tolterodine
tartrate)
Extended-Release
Capsules,
Pfizer
Global
Research
and
Development,
Labeling
Revision
-
Naproxen
Sodium
Tablets,
Granules
India
Ltd.,
Approval
-
Ranitidine
Hydrochloride
Syrup,
Sun
Pharmaceutical
Industries,
Inc.,
Approval
-
Tramadol
Hydrochloride
Extended-Release
Tablets,
Par
Pharmaceutical,
Inc.,
New
Dosage
-
Tricor
(fenofibrate)
Tablets,
Abbott
Laboratories,
Labeling
Revision
September
21, 2011
-
Enoxaparin
Sodium
Injection,
Amphastar
Pharmaceuticals,
Inc.,
Approval
-
Lovaza
(omega-3-acid
ethyl
esters)
Capsules,
GlaxoSmithKline
LLC,
Labeling
Revision
-
Vancomycin
Hydrochloride
Injection,
Strides
Inc.,
Approval
-
Viread
(tenofovir
disoproxil
fumarate)
Tablets,
Gilead
Sciences,
Inc.,
Efficacy
Supplement
with
Clinical
Data to
Support
September
20, 2011
-
Atripla
(efavirenz,
emtricitabine
and
tenofovir
disoproxil
fumarate)
Tablets,
Gilead
Sciences,
Inc.,
Labeling
Revision
-
Enoxaparin
Sodium
Subcutaneous
Injection,
Amphastar
Pharmaceuticals,
Inc.,
Approval
-
Levetiracetam
Extended-Release
Tablets,
Actavis
Elizabeth
LLC,
Approval
-
Levofloxacin
and
Dextrose
(5%) in
Plastic
Container
Injection,
Hikma
Farmaceutica,
Approval
-
Lovaza
(omega-3-acid
ethyl
esters)
Capsules,
GlaxoSmithKline
LLC,
Labeling
Revision
-
Naproxen
Delayed-Release
Tablets,
Invagen
Pharmaceuticals,
Inc.,
Approval
-
Norethindrone
Tablets,
Lupin
Ltd.,
Approval
-
Noroxin
(norfloxacin)
Tablets,
Merck
Sharp &
Dohme
Corp.,
Labeling
Revision
-
Simvastatin
Tablets,
Micro
Labs
Ltd.,
Approval
-
Stimate
(desmopressin
acetate)
Nasal
Spray,
CSL
Behring,
Labeling
Revision
-
Vancomycin
Hydrochloride
Injection,
Agila
Specialties
Private
Ltd.,
Approval
|
|
|
-
Center
for
Drug
Evaluation
and
Research,
Approach
to
Addressing
Drug
Shortage;
Public
Workshop,
September
26,
2011,
10903
New
Hampshire
Ave.,
Bldg.
31,
Rm.
1503
B
and
C
(Great
Room),
Silver
Spring,
MD.
Meeting
information
-
CDER
Small
Business
Assistance
Industry
Workshop:
Clinical
Trials
and
Electronic
Submissions,
September
26-27,
2011,
Los
Angeles,
CA
and
September
28-29,
2011,
San
Francisco,
CA.
Meeting
information
-
CDER
Forum
for
International
Drug
Regulatory
Authorities,
October
17-21,
2011,
College
Park,
MD. Meeting
information
-
2011
RAPS:
The
Regulatory
Convergence,
October
22-26,
2011, Meeting
information
and
registration
-
DIA/FDA
Tailored
Therapeutics:
Practical
Issues
and
Methodologies
for
Selecting
the
Right
Patients,
October
25-26,
2011,
Bethesda
North
Marriott
Hotel
and
Conference
Center,
5701
Marinelli
Road,
North
Bethesda,
MD 20852.
Meeting
information
and
registration
-
FDA
Clinical
Investigator
Training
Course,
November
7-9,
2011.
Meeting
information
|
|
|
|
Guidance
Approved Drugs
Approval Process
Electronic Submissions
Firm Registration Status
Good Manufacturing Practice
Regulations
National Drug Code Directory
MedWatch: Adverse Event Reporting
Download Forms
Generic Drugs
Small Business
En Español
|
|
|
CBER NEWS |
-
Updated
Agenda:
The
Development
and
Evaluation
of
Next-Generation
Smallpox
Vaccines,
September
16,
2011 (PDF
-
31KB)
Posted:
9/23/2011
-
September
19,
2011
Approval
Letter
-
IMOVAX
Posted:
9/23/2011
-
Influenza
Virus
Vaccine
for
the
2011
-
2012
Season
Updated:
9/21/2011
-
September
22,
2011:
Cellular,
Tissue
and
Gene
Therapies
Advisory
Committee
Meeting
Final
Agenda
Posted:
9/21/2011
-
September
23,
2011:
Cellular,
Tissue
and
Gene
Therapies
Advisory
Committee
Meeting
Final
Agenda
Posted:
9/21/2011
-
September
20,
2011:
Vaccines
and
Related
Biological
Products
Advisory
Committee
Meeting
Public
Roster
Posted:
9/20/2011
-
September
20,
2011:
Vaccines
and
Related
Biological
Products
Advisory
Committee
Meeting
Agenda
Posted:
9/20/2011
-
September
22,
2011:
Cellular,
Tissue
and
Gene
Therapies
Advisory
Committee
Meeting
Materials
Posted:
9/20/2011
-
September
23,
2011:
Cellular,
Tissue
and
Gene
Therapies
Advisory
Committee
Meeting
Materials
Posted:
9/20/2011
|
|
|
- Two-day Tissue Adhesives / Soft Tissue Workshop / Symposium, September 26-27, 2011
September 26-27, 2011, FDA White Oak Campus, Building 2, Silver Spring, Maryland
- FDA Clinical Investigator Training Course
November 7-9, 2011, Silver Spring, MD
- Public Workshop - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors
November 8-9, 2011, Natcher Conferencer Center, Building 45, National Institutes of Health, Bethesda, MD 20894
- Public Workshop - Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products
November 29, 2011
|
|
|
|
About
CBER
CBER
Vision
&
Mission
Biologics
Research,
Regulatory
Information,
Safety
&
Availability,
Guidances,
Development
&
Approval,
Enforcement
&
Compliance
News
&
Events
(Biologics)
What's
New,
Meetings
&
Workshops
CBER
Reports
CBER
Annual
Report,
Performance,
FDAMA,
PDUFA,
FDAAA,
PREA
Biologics
Regulated
Products
Allergenics,
Blood
&
Blood
Products,
Cellular
&
Gene
Therapy
Products,
Tissue
&
Tissue
Products,
Vaccines,
Xenotransplantation
Contacts
in
the
Center
for
Biologics
Evaluation
&
Research
(CBER)
Consumer
questions,
manufacturer's
assistance,
media
inquiries,
technical
questions,
requesting
speakers,
establishment
registration...
Jobs
at
the
Center
for
Biologics
Evaluation
and
Research
(CBER)
Frequently
Asked
Questions
about
the
Center
for
Biologics
Evaluation
and
Research
(CBER)
and
the
Products
CBER
Regulates
Biologics
Electronic
Reading
Room
(eFOI)
Documents
frequently
requested
through
the
Freedom
of
Information
Act.
|
|
|
CDRH NEWS |
September 21, 2011
September 20, 2011
September 19, 2011
|
|
|
-
2011 RAPS: The
Regulatory Convergence,
October 22-26, 2011
-
AdvaMed 2011 - The
MedTech Conference,
September 26-28, 2011
-
Town Hall Discussion
With the Director of
CDRH and Other Senior
Center Management,
September 22, 2011
-
2011 PDA/FDA Joint
Regulatory Conference,
September 19-21, 2011
-
Center for Devices and
Radiological Health
Forum for International
Medical Device
Regulatory Authorities
(Advanced Session),
September 13-16, 2011
-
Unique Device
Identification (UDI) for
Postmarket Surveillance
and Enforcement Public
Workshop, September
12-13, 2011
|
|
|
|
Guidance Documents (Medical Devices)
How to Market Your Device
Postmarket Requirements (Devices)
Importing and Exporting Devices
International Information (Devices)
Device Classification
Bioresearch Monitoring
FDA eSubmitter
CDRH Learn |
|
|
|
|
|
|
RULES - 520 Change |
Oral Dosage Form New Animal
Drugs:
Tylosin
59023–59024 [2011–24461]
[TEXT] [PDF]
|
|
PROPOSED RULES - NONE |
|
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
New Animal Drugs for Investigational Uses
59139–59141 [2011–24433]
[TEXT] [PDF]
Determinations that Drug
Products were Not Withdrawn
from Sale for Reasons of
Safety or Effectiveness:
LOXITANE Capsules, et al.
59141 [2011–24402]
[TEXT] [PDF]
Guidance for Industry;
Availability:
Reproductive and Developmental Toxicities – Integrating
Study Results to Assess
Concerns
59142 [2011–24431]
[TEXT] [PDF]
Meetings:
Advisory Committee for Reproductive Health Drugs and
Drug Safety and Risk
Management Advisory
Committee
59143–59144 [2011–24532]
[TEXT] [PDF]
Advisory Committee for Reproductive Health Drugs and
the Drug Safety and Risk
Management Advisory
Committee
59142–59143 [2011–24533]
[TEXT] [PDF]
Withdrawal of Approval of 27
New Drug Applications and 58
Abbreviated New Drug
Applications:
Novartis Pharmaceuticals Corp. et al.; Correction
59144 [2011–24400]
[TEXT] [PDF]
|
|
|
|
RULES - NONE |
|
|
|
PROPOSED RULES - NONE |
|
|
|
NOTICES |
Guidance for Industry;
Availability:
Measures to Address the Risk for Contamination by
Salmonella Species in Food
Containing Pistachio, etc.
58813 [2011–24317]
[TEXT] [PDF]
|
|
|
|
RULES - No Rule Change |
Revised Guidance on Marketed
Unapproved Drugs;
Availability:
Marketed New Drugs Without Approved NDAs or ANDAs
58398–58399 [2011–24316]
[TEXT] [PDF]
|
|
PROPOSED RULES - NONE |
|
|
|
NOTICES |
Meetings:
Pediatric Oncology Subcommittee of Oncologic Drugs
Advisory Committee
58520 [2011–24162]
[TEXT] [PDF]
Risk Communication Advisory Committee
58519–58520 [2011–24168]
[TEXT] [PDF]
|
|
|
|
RULES - NONE |
|
|
|
PROPOSED RULES - NONE |
|
|
|
NOTICES |
Meetings:
Animal Drug User Fee Act
58279–58281 [2011–24082]
[TEXT] [PDF]
Animal Generic Drug User Fee Act
58277–58279 [2011–24083]
[TEXT] [PDF]
Public Workshops:
Magnetic Resonance Imaging Safety
58281–58282 [2011–24030]
[TEXT] [PDF]
|
|
|
|
RULES - 522 & 556 Change |
Implantation or Injectable
Dosage Form New Animal
Drugs:
Ivermectin
57905–57906 [2011–23865]
[TEXT] [PDF]
New Animal Drugs:
Gamithromycin
57906–57907 [2011–23874]
[TEXT] [PDF]
Tolerances for Residues of
New Animal Drugs in Food:
Progesterone
57907 [2011–23867]
[TEXT] [PDF]
|
|
PROPOSED RULES - NONE |
|
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Experimental Study; Effect of Promotional Offers in
Direct-to-Consumer
Prescription Drug Print
Advertisements on Consumer
Product Perceptions
58011–58018 [2011–23926]
[TEXT] [PDF]
Draft Guidance for Industry
on Self-Selection Studies
for Nonprescription Drug
Products; Availability
58018 [2011–23927]
[TEXT] [PDF]
Meetings:
Circulatory System Devices Panel of the Medical Devices
Advisory Committee
58019–58020 [2011–23875]
[TEXT] [PDF]
Tobacco Products Scientific Advisory Committee
58019 [2011–23868]
[TEXT] [PDF]
Prescription Drug User Fee
Act IV Information
Technology Plan;
Availability
58020–58021 [2011–23923]
[TEXT] [PDF]
|
|
|
|
|
|
|
 |
|
 Advertise on GXPNews 856-810-1825! |
|
 |
FDA CFR
Pocket Size
Handbooks
-
more...
Download
Fax Form |
|
Get your copy - FDA handbooks |
|
Parts 210/211 Drug GMPs |
|
Part 820 Quality Systems |
|
Parts 11, 210/211 & 820 |
|
GMP Standard Combo - Parts 11,
210/211, 820 & ICH Q7 |
|
Medical Device - 11, 50, 54, 56,
807, 812, 814, 820, PMA/510k |
|
Clinical GCP - Parts
11,50,54,56,312,314 ICH E2A & E6 |
|
Multi - US GMP - Parts 11, 58,
210/211, 600, 601, 610 & 820 |
|
EU GMP 1-9, US GMP 11, 210/211, 820
& ICH Q7, Q8, Q9 & Q10 |
|
Biologic GMPs - Parts 600, 601, 610 |
|
ICH Combination Q7, Q8, Q9 & Q10
Quality Handbook |
|
Dietary Supplement GMPs - Part 111
|
|
US-EU-Japanese GMP Handbook |
|
EU Basic GMP Handbook Chapter 1-9 |
|
210/211 - with Keyword Index |
|
210/211
- with Part 11 |
|
Part 11
- with Part 820 |
|
21 CFR Part 58 Good Laboratory
Practice |
|
GMP Auditor’s Basics |
|
GLP Master Guide Handbook |
|
GCP
Clinical Master Reference |
|
US-EU-Canadian
Device handbook |
|
Canadian GMPs
- 2009
-
Canadian Medical Device |
|
Pharmacovigilance Volume 9a |
|
Food/Supplements GMPs |
|
Quality Systems Manual |
|
QSIT
Manuals |
|
EU/US Combo
Handbooks |
|
Electronic Systems Master Handbook |
|
Part 606 Blood Industry GMPs |
|
|
The e-Newsletter of
What's New with CDER, CDRH & CBER
Distributed by the worlds
leader in Federal Regulations,
GMP Publications, Inc. & FDA.COM
Tel: 866-GXPNews (or 856-810-7331) Fax: 856-810-7339
http://www.gmppublications.com /
http://www.fda.com
John Cuspilich, Sr. Editor, GXPNews
If you would like to advertise in this eNewsletter, call
856-810-1825
|
