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GXPNews.com - FDA News and Announcements - March 19, 2007 - March 23, 2007

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
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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

CDER Links

CBER Links

CDRH Links

March 23, 2007

Guidance for Industry and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees [PDF]
Pediatrics: PREA Labeling Changes
New and Generic Drug Approvals
- Calcipotriene Topical Solution, Hi-Tech Pharmacal, Tentative Approval
- Chlorascrub Swab, Nice Pak Products, Package Change
- Colgate Total Toothpaste, Colgate-Palmolive, Formulation Revision
- Hydroxyzine Hydrochloride (10mg) Tablets, KVK-Tech Inc., Approval
- Hydroxyzine Hydrochloride (25mg) Tablets, KVK-Tech Inc., Approval
- Hydroxyzine Hydrochloride (50mg) Tablets, KVK-Tech Inc., Approval
- Keppra (levetiracetam) Tablets, UCB Inc., New or Modified Indication
- Keppra (levetiracetam) Oral Solution, UCB Inc., New or Modified Indication
- Lamivudine Tablets, Matrix Labs, Tentative Approval
- Megace ES (megestrol acetate) Oral Suspension, Par Pharma, Labeling Revision
- Oxycodone Hydrochloride Tablets, Tyco Healthcare Mallinckrodt, Approval
- Prilosec OTC (omeprazole magnesium) tablets, Procter & Gamble, Labeling Revision
- Sertraline Hydrochloride Tablets, Genpharm Inc., Approval
- Sumatriptan Succinate Tablets, Roxane Labs, Tentative Approval
- Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision

March 22, 2007

Drugs@FDA Downloadable Data Files (updated)
New and Generic Drug Approvals
- Detrol (tolterodine tartrate) Tablets, Pfizer, Labeling Revision
- Detrol LA (tolterodine tartrate) Extended Release Capsules, Pfizer, Labeling Revision
- Dolobid (diflunisal) Tablets, Merck & Co., Labeling Revision
- Hydrochlorothiazide Tablets, Excellium Pharma, Approval
- Monistat 3-Combination Pack (miconazole nitrate) Vaginal Suppositories & Cream, Personal Products Co., Formulation Revision
- Propoxyphene Napsylate & Acetaminophen Tablet, Wockhardt Ltd., Approval
- Ribavirin Tablets, Zydus Pharma, New Strength

March 20, 2007

Office of Generic Drugs: Approved Discontinued Drug Products Safety and Effectiveness Determinations
Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

March 19, 2007

Guidance for Industry: Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2007
Cosmos Trading, Inc. and FDA notify consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max. MedWatch Safety Information
New and Generic Drug Approvals
- Azathioprine Tablets, Zydus Pharma, Approval
- Ceftriaxone Injection, Sicor Pharma, Approval
- Prozac (fluoxetine) Pulvules, Eli Lilly & Co., Labeling Revision
- Prozac Oral Suspension, Eli Lilly & Co., Labeling Revision
- Prozac Weekly Delayed Release Capsule, Eli Lilly & Co., Labeling Revision
- Ranitidine Syrup, Pharma Assoc., Tentative Approval
- Tiagabine Hydrochloride Tablets, Sun Pharma, Tentative Approval
- TIMENTIN (sterile ticarcillin disodium/clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
- TIMENTIN Galaxy (PL2040) Plastic Container (sterile ticarcillin disodium/clavulanate potassium) , GlaxoSmithKline, Labeling Revision
- Venlafaxine Hydrochloride Tablets, Zydus Pharma, Tentative Approval
- Zolpidem Tartrate Tablets, Ranbaxy Labs, Tentative Approval
BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Statistics (updated)

CDER Drug Links

Drug Master Files - CBER Processes and Review - Slide Presentation
Posted: 3/23/2007

Influenza Virus Vaccine 2007-2008 Season
Posted: 3/21/2007

Postmarketing Monitoring of Intussusception After RotaTeq Vaccination --- United States, February 1, 2006--February 15, 2007 (MMWR)
Posted: 3/21/2007

New

FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing - 4/25-26/2007

National Foundation for Infectious Diseases: 10th Annual Conference on Vaccine Research - 4/30/2007-5/2/2007

Drug Master Files - CBER Processes and Review (PDF - 156 KB) - Jay Eltermann, R.Ph., M.S.

Regulatory Pathways: What Regulations Apply - Ruth Solomon, M.D.

Quality Program, CAPA and Audits - Mary Malarkey

Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials - Patricia Holobaugh

The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions - Patricia Holobaugh

CBER Links

March 22, 2007
	Federal Register: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting.
	Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, February 22, 2007 - Transcript

March 21, 2007
	Japan - U.S. "Harmonization By Doing" HBD Pilot Program Initiative (Updated 3/21/2007)

March 19, 2007
	Class I Medical Device Recall: HoMedics Thera-P Heating Pads
	Neurological Devices Panel Advisory Meeting, January 26, 2007 - Transcript

News & Events
Japan - U.S. "Harmonization By Doing" HBD Pilot Program Initiative (Updated 3/21)
Update to FDA Statement on Coronary Drug-Eluting Stents
Approval of Allergan and Mentor Silicone Gel-Filled Breast Implants
Public Health Notifications: • Custom Ultrasonics, Inc. Endoscope Washer/Disinfectors • Unpredictable Events in Medical Equipment due to New Daylight Savings Time Change
Class I Medical Device Recalls - • HoMedics Thera-P Heating Pads • LifeLine Semi-Automatic External Defibrillators (AEDs) and ReviveR Semi-Automatic External Defibrillators (AEDs) • Bard Composix Kugel Mesh Patch - Expansion • Counterfeit OneTouch Basic/Profile and Ultra Blood Glucose Test Strips
FDA Patient Safety News - A Video News Show for Health Professionals

Medical Device Links

Industry Assistance

Health Topics

About CDRH

Device Program Areas

Radiological Health

CFR Rule Changes - 341

Friday, March 23, 2007

NOTICES
Reports and guidance documents; availability, etc.:
FDA Advisory Committees; members and staff procedures for determining conflict of interest and eligibility for participation; draft guidance,
13805–13806 [07–1459] [TEXT] [PDF]

Thursday, March 22, 2007

NOTICES
Agency information collection activities; proposals, submissions, and approvals,
13498–13499 [E7–5195]   [TEXT]  [PDF]
13499–13500 [E7–5196]   [TEXT]  [PDF]

Committees; establishment, renewal, termination, etc.:
     Public advisory committees—
     Voting members,
     13500–13501 [E7–5193]   [TEXT]  [PDF]

Meetings:
      Pulmonary-Allergy Drugs Advisory Committee,
     13501–13502 [E7–5194]   [TEXT]  [PDF]

Wednesday, March 21, 2007

NOTICES
Meetings:
     Medical Devices Advisory Committee,
     13288–13289 [E7–5152]   [TEXT]  [PDF]
     Science Advisory Board,
     13289 [E7–5153]   [TEXT]  [PDF]

Tuesday, March 20, 2007

NOTICES
Agency information collection activities; proposals, submissions, and approvals,
13117–13118 [E7–5046] [TEXT] [PDF]

Monday, March 19, 2007

RULES
Human drugs:
     Cold, cough, allergy, bronchodilator, and antiasthmatic products (OTC)—
     Combination products; final monograph; technical correction,
     12730 [E7–4957]   [TEXT]  [PDF]

NOTICES
Meetings:
     Pediatric Advisory Committee,
     12806–12807 [E7–4877]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Labeling for human prescription drug and biological products—
     Indexing structured product labeling; industry guidance,
     12807–12808 [E7–4881]   [TEXT]  [PDF]

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FDA Handbooks

US GMP Training Booklet
- Parts 11 Electronic Systems
- 58 Good Lab. Practices
- 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

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 & 210/211 w/ Keyword Index

11 & 820 Electronic Record and Quality Systems

Biological GMPs 600, 601, 610

more...

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