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 |
April 13,
2007
- Drug Approval
Reports: Approval Rates by
Cohort Year of Receipt (Fiscal
Years)
- FDA approves
Altabax (retapamulin ointment)
for topical treatment of
impetigo, a skin infection
caused by bacteria.
FDA News
- FDA will hold
a public hearing on the
medication guide program with
the goal of improving risk
communication.
FDA News
-
New and Generic
Drug Approvals
-
Femara
(letrozole) Tablets,
Novartis Pharma, Labeling
Revision
-
Fosphenytoin
Sodium Injection, Abraxis
Pharma, Tentative Approval
-
Galantamine
Hydrobromide Tablets, Apotex
Inc., Tentative Approval
-
Glipizide
and Metformin Hydrochloride
Tablets, Approval
-
Granisetron
Hydrochloride Tablets,
CorePharma, Tentative
Approval
-
Loratadine
Orally Disintegrating
Tablets, Ranbaxy Labs,
Approval
-
Nicardipine
Hydrochloride Capsules, Barr
Labs, Facility Addition
-
Novantrone
(mitoxantrone) Injection,
EMD Serono Inc.,
Manufacturing Change or
Addition
- Office of
Generic Drugs:
March First-Time Generic Drug
Approvals
April 12,
2006
April 11,
2006
April 10,
2006
April 9,
2006
-
Prescription Drug
User Fee Act (PDUFA) Therapeutic
Biologic Billable Products
- Public
Hearing on Use of Medication
Guides to Distribute Drug Risk
Information to Patients, June
12-13, 2007.
Meeting
Information
-
New and Generic
Drug Approvals
-
Abacavir
Sulfate Tablets, Matrix
Labs, Tentative Approval
-
SARAFEM
(fluoxetine hydrochloride)
Tablets, Warner Chilcott,
Labeling Revision
-
Cefdinir
Capsules, Sandoz Inc.,
Approval
-
Cefdinir
Oral Suspension, Sandoz
Inc., Approval
-
Fludarabine
Phosphate Injection, Mayne
Pharma, Approval
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April
12, 2007 |
 |
Consumer Information
on: Histoacryl and
Histoacryl Blue -
P050013
 |
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Consumer Information
on: Paradigm
REAL-Time and
Guardian REAL-Time
Systems -
P980022S015
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April
11, 2007 |
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General Hospital and
Personal Use Devices
Panel Advisory
Meeting, May 4, 2007
- Notice of Meeting
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April
10, 2007 |
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Boston Scientific /
Guidant Recall:
Questions & Answers
(April 10, 2007)
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April
9, 2007 |
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Federal Register:
General Hospital and
Personal Use Devices
Panel of the Medical
Devices Advisory
Committee; Notice of
Meeting
 |
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Federal Register:
Medical Devices;
Technical Amendment
|
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Medical Device Links
|
Industry
Assistance
Health
Topics
About
CDRH
Device
Program Areas
Radiological
Health
|
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|
Weekly
CFR Rule Changes -
524
- 179-803-814-820-821-822-874-886-1002-1005-1020
NOTE: Med
Device Handbooks have been
updated for April 9th. |
|
Friday,
April 13, 2007 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
1865918660 [E76983]
[TEXT] [PDF]
Meetings:
Supplements; chemistry,
manufacturing, controls, and
changes to approved
marketing applications,
1866018661 [E76985]
[TEXT] [PDF]
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Thursday,
April 12, 2007 |
NOTICES
Meetings:
Anti-Infective Drugs
Advisory Committee,
18483 [071825]
[TEXT] [PDF]
|
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Wednesday,
April 11, 2007 |
RULES
Animal drugs, feeds, and
related products:
Mupirocin ointment,
1811818119 [E76828]
[TEXT] [PDF]
NOTICES
Food additive petitions:
Durand-Wayland, Inc.,
18263 [E76765]
[TEXT] [PDF]
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Tuesday,
April 10, 2007 |
NONE
|
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Monday,
April 9, 2007 |
RULES
Food for
human consumption:
Irradiation in production,
processing, and handling of
food
Ionizing radiation in
treatment of food; x-ray
maximum permitted energy
level,
1739417397 [E76646]
[TEXT] [PDF]
Medical
devices:
Technical amendments,
1739717401 [E76290]
[TEXT] [PDF]
NOTICES
Human drugs:
New drug applications
King Pharmaceuticals, Inc.,
et al.; approval withdrawn,
1755617558 [E76593]
[TEXT] [PDF]
Meetings:
Blood Products Advisory
Committee,
17558 [E76594]
[TEXT] [PDF]
Medical Devices Advisory
Committee,
1755817559 [E76645]
[TEXT] [PDF]
Medication guides use to
distribute drug risk
information to patients;
hearing,
1755917561 [E76506]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Dosage and administration
section of labeling for
human prescription drug and
biological products; content
and format,
1756117562 [E76508]
[TEXT] [PDF]
Human subject protection,
improvement; adverse event
reporting; clinical
investigators, sponsors, and
investigational review
boards guidance,
1756217563 [E76595]
[TEXT] [PDF]
Orally disintegrating
tablets,
1756317564 [E76509]
[TEXT] [PDF]
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US GMP Training Booklet
Parts 11 - 58 GLP
-
210/211 Drug GMPs
- 820 Quality Systems
- "GMPs for the 21st.
Century"
- "Quality Systems Approach
to GMPs" |
|
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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The e-Newsletter of
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