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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April 6, 2007
April 5,
2007
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National Drug
Code Directory Download
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National Drug
Code Directory Search
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New and Generic
Drug Approvals
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Acetaminophen,
Caffeine, and Dihydrocodeine
Bitartrate Capsules, Boca
Pharmacal, Approval
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Acetaminophen,
Caffeine, and Dihydrocodeine
Bitartrate Tablets, Boca
Pharmacal, Approval
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Cefaclor
Capsules, Hikma Pharma,
Approval
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Hydrocodone
Bitartrate and Ibuprofen
Tablets, Vintage Pharma,
Labeling
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INVIRASE
(saquinavir mesylate)
Capsules, Hoffman-La Roche,
Labeling Revision
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INVIRASE
(saquinavir mesylate) Film
Coated Tablets, Hoffman-La
Roche, Labeling Revision
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Minocin
(minocycline) Pellet-Filled
Capsules, Triax Pharma,
Labeling Revision
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Norflex
(Orphenadrine Citrate)
Extended-Release Tablets and
Injection, Graceway Pharma,
Labeling Revision
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Tygacil
(tigecycline) Injection,
Wyeth Pharma, Labeling
Revision
April 4,
2007
April 3,
2007
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New and Generic
Drug Approvals
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Avandaryl
(rosiglitazone maleate and
glimepiride) Tablets, SB
Pharmco, Manufacturing
Change or Addition
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Benzonatate
Capsules, The Pharma
Network, Approval
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Benzphetamine
Hydrochloride Tablets, Tedor
Pharma, Approval
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Carboplatin
Injection, Sicor Pharma,
Approval
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Cordarone
(amiodarone HCl) Tablets,
Wyeth Pharma, Labeling
Revision
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Galantamine
Hydrobromide Tablets, Watson
Labs, Tentative Approval
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Hydrocortisone
Tablets, Stiefel Labs,
Approval
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Isosorbide
Dinitrate Tablets, West-Ward
Pharma, Control Supplement
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Janumet
(sitagliptin/metformin
hydrochloride) Tablets,
Merck & Co., Approval
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Nadolol/Bendroflumethiazide
Tablets, Impax Labs,
Approval
April 2,
2007
- FDA approves
first-time generic nadolol/
endroflumethiazide tablets to
treat hypertension. The
reference listed drug is Corzide.
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New and Generic
Drug Approvals
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Albuterol
Sulfate and Ipratropium
Bromide Inhalation Solution,
Apotex, Tentative Approval
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Ambien
(zolpidem tartrate) Tablets,
Sanofi-Aventis, Patient
Population Altered
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Carnitor
(levocarnitine) Tablets,
Sigma-Tau Pharma, Labeling
Revision
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Carnitor
(levocarnitine) Oral
Solution, Sigma-Tau Pharma,
Formulation Revision
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Clindamycin
Injection, Abraxis Pharma,
Approval
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Meloxicam
Tablets, Aurobindo Pharma,
Labeling
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Naproxen
Tablets, Glenmark Pharma,
Approval
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Uroxatral
(alfuzosin HCl)
Extended-Release Tablets,
Sanofi-Aventis, Labeling
Revision
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Visudyne
(verteporfin) Injection, QLT
Inc., Labeling Revision
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FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients
Posted: 4/6/2007Supplement Approval: Hepatitis B Immune Globulin Intravenous (Human) (HepaGam B) - Cangene Corp
Posted: 4/6/2007, Approval Date: 4/6/2007
Blood Products Advisory Committee Meeting
Posted: 4/6/2007; Meeting Date: 4/26-27, 2007
Licensed Products and Establishments List - Update
Posted: 4/6/2007, Updated through: 3/31/2007
Approved Biological NDA and ANDA Applications - Update
Posted: 4/6/2007, Updated through: 3/31/2007
Cleared Biological 510(k) Device Applications - Update
Posted: 4/6/2007, Updated through: 3/31/2007
Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 4/6/2007, Updated through: 3/31/2007
Workshop: Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing - Agenda
Posted: 4/6/2007, Workshop Dates: 4/25-26/2007
Supplement Approval: Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil) - Merck & Co., Inc
Posted: 4/4/2007, Approval Date: 4/3/2007
Vacancy Announcement - Biologist, LMD/DVP/OVRR
Posted: 4/4/2007
Supplement Approval: Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine (TWINRIX) - GlaxoSmithKline Biologicals
Posted: 4/3/2007, Approval Date: 3/28/2007
Vacancy Announcement - Research Microbiologist, LH/DVP/OVRR
Posted: 4/3/2007
FDA Approves First Biologic to Treat Rare Clotting Disorder
Posted: 4/3/2007
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update
Posted: 4/2/2007, Updated as of: 3/28/2007
Donor Screening Tests for Testing HCT/P Donors - CMV table updated
Posted: 4/2/2007
Warning Letter - Sanochemia Pharmazeutika AG
Posted: 4/2/2007; Issued: 3/19/2007
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April
6, 2007 |
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FDA
Provides Web Access
to Information on
Post-Approval Device
Studies
 |
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Medical Devices
Dispute Resolution
Panel Advisory
Meeting, April 19,
2007 - Notice of
Upcoming Meeting
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PMA
Post Approval
Studies
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April
5, 2007 |
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510(k) Final
Decisions - March
2007
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April
3, 2007 |
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Guidance for
Industry and FDA
Staff - Class II
Special Controls
Guidance Document:
Herpes Simplex Virus
Types 1 and 2
Serological Assays
 |
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Federal Register:
Guidance for
Industry and Food
and Drug
Administration
Staff; Class II
Special Controls
Guidance Document:
Herpes Simplex Virus
Types 1 and 2
Serological Assays;
Availability.
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Federal Register:
Medical Devices;
Availability of
Safety and
Effectiveness
Summaries for
Premarket Approval
Applications
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Federal Register:
Microbiology
Devices;
Reclassification of
Herpes Simplex Virus
Types 1 and 2
Serological Assays.
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April
2, 2007 |
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Medical Device
Safety Article:
Pneumatic Tourniquet
Cuffs, with the
Tourniquet Systems
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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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Weekly
CFR Rule Changes -
866 -
520 -
558 |
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Friday,
April 6, 2007 |
NONE
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Thursday,
April 5, 2007 |
NOTICES
Meetings:
Pharmaceutical Science and
Clinical Pharmacology
Advisory Committee;
canceled,
16797 [E7–6283]
[TEXT] [PDF]
16797 [E7–6288]
[TEXT] [PDF]
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Wednesday,
April 4, 2007 |
RULES
Animal drugs, feeds, and
related products:
Melengestrol and lasalocid,
16270 [E7–6180]
[TEXT] [PDF]
Praziquantel and pyrantel,
16270 [E7–6181]
[TEXT] [PDF]
PROPOSED
RULES
Food for human consumption:
Food labeling—
Irradiation in the
production, processing and
handling of food,
16291–16306 [07–1636]
[TEXT] [PDF]
NOTICES
Meetings:
Harmonisation International
Conference—
Rockville, MD; preparation
and topics discussion,
16370–16371 [07–1633]
[TEXT] [PDF]
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Tuesday,
April 3, 2007 |
RULES
Medical
devices:
Immunology
and microbiology devices—
Herpes simplex virus types 1
and 2 serological assays;
reclassification,
15828–15830 [E7–6167]
[TEXT] [PDF]
NOTICES
Medical
devices:
Premarket
approval applications, list;
safety and effectiveness
summaries availability,
15885–15886 [E7–6166]
[TEXT] [PDF]
Meetings:
Oncologic Drugs Advisory
Committee,
15886–15887 [E7–6171]
[TEXT] [PDF]
Reports and
guidance documents;
availability, etc.:
Animal cloning risk
assessment plan; industry
guidance,
15887–15888 [E7–6170]
[TEXT] [PDF]
Herpes simplex virus types 1
and 2 serological assays;
Class II special controls,
15888–15889 [E7–6168]
[TEXT] [PDF]
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Monday,
April 2, 2007 |
NOTICES
Biological
products:
Patent extension; regulatory
review period
determinations—
KEPIVANCE,
15699–15700 [E7–6053]
[TEXT] [PDF]
Human drugs:
Patent extension; regulatory
review period
determinations—
RANEXA,
15700–15701 [E7–6061]
[TEXT] [PDF]
Meetings:
FDA-Orange County Regulatory
Affairs Educational
Conference,
15701 [E7–6052]
[TEXT] [PDF]
Prescription drug products;
prescribing information;
electronic distribution;
hearing,
15701–15703 [07–1604]
[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" |
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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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