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GXPNews.com - FDA News and Announcements - December 17, 2007 - December 21, 2007

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
Distributed by the worlds leader in Federal Regulations, GMP Publications & FDA.COM - John Cuspilich RA/QA Editor

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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

View CDER Handbooks

View CBER Handbooks

View CDRH Handbooks

December 21, 2007

Guidance for Industry: Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act [PDF]
BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting information
FDA updates the Public Health Advisory and Information for Healthcare Professionals sheet for fentanyl transdermal system (Duragesic and generics). MedWatch Safety Information
New and Generic Drug Approvals
- Buspirone Hydrochloride, Tablet, Actavis Totowa, Approval
- Bystolic (nebivolol), Tablet, Mylan Bertek, Approval
- Efavirenz, Tablet, Emcure, Tentative Approval
- Extended Phenytoin Sodium, Capsule, Wockhardt, Approval
- Levalbuterol Hydrochloride, Inhalation Solution, Breath Ltd, Tentative Approval
- Metronidazole, Topical Cream, G & W Laboratories, Approval
- Pantoprazole Sodium, Extended Release Tablet, Dr. Reddy's Labs, Tentative Approval

December 20, 2007

FDA provides information about new adverse event reporting requirements for manufacturers, packers, or distributors of dietary supplements and non-prescription (OTC) drug products marketed without an approved application. MedWatch Information

December 19, 2007

Drugs@FDA Downloadable Data Files (updated)
Office of Generic Drugs: November First-Time Generic Drug Approvals
Paragraph IV Patent Certifications (updated)

December 18, 2007

Adverse Drug Experience Reporting (updated)

December 17, 2007

Current Drug Shortage: Tc99: Multiple diagnostic products which utilize Tc99 generators
New and Generic Drug Approvals
- Cefdinir Oral Suspension, Aurobindo Pharma, Approval
- DepoDur (morphine sulfate extended-release liposome) Injection, Pacira Pharma, Labeling Revision
- Effexor XR (venlafaxine HCl) Extended-Release Capsules, Wyeth Pharma, New Modified Indication
- Heparin Sodium Injection, Abraxis Pharma, Labeling Revision
- Heparin Sodium Injection Baxter Healthcare, Labeling Revision
- LEXIVA (fosamprenavir calcium) Oral Tablets, GlaxoSmithKline, Labeling Revision
- Methimazole Tablets, Actavis, Approval
- Omniscan (gadodiamide) Injection, GE Healthcare, Labeling Revision
- Paromomycin Sulfate Capsules, X-Gen Pharma, Approval
- Thyrogen (thyrotropin alfa) Injection, Genzyme Corp., New or Modified Indication

CDER Drug Links

Biological Product Shortages - Haemophilus influenza Type b (Hib) Conjugate (PedvaxHIB and Comvax)
Posted: 12/20/2007

Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) - Form
Posted: 12/20/2007

Cellular, Tissue and Gene Therapies Advisory Committee Meeting
Posted: 12/20/2007, Meeting Date: 4/10-11/2008

Vacancy Announcement - Regulatory Information Specialist, DCC/ADRM/OM
Posted: 12/20/2007

Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB and Comvax)
Posted: 12/19/2007

WilBio 2nd Annual Cell Banking Meeting - Slide Presentation
Posted: 12/19/2007

User Fee Billable Products Approved Under Section 351 of the PHS Act - Update
Posted: 12/18/2007

Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Webcast
Posted: 12/18/2007

Vacancy Announcement - Chemist, LRSP/DBPAP/OVRR
Posted: 12/18/2007

Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
Posted: 12/17/2007

PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] - Recall
Posted: 12/17/2007

December 21, 2007
	FDA Medical Device Industry Coalition - 'Quality Systems Educational Forum on Design Controls
	Consumer Information on: ProDisc-C Total Disc Replacement - P070001

December 19, 2007
	eMDR: electronic Medical Device Reporting
	Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the list of Recognized Standards, Recognition List Number: 019.
	Guidance for Medical Gloves - A Workshop Manual
	Federal Register: Medical Devices, Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.

December 18, 2007
	Obstetrics and Gynecology Devices Panel Advisory Meeting, December 13-14, 2007 - Brief Summary

December 17, 2007
	Maturity Health Matters - Fall/Winter 2007-2008 Issue
	PMA Final Decisions for November 2007

Medical Device Links

Industry Assistance

Weekly CFR
Rule Changes - 201

Friday, Dec. 21, 2007

NOTICES
Meetings:
     Pulmonary-Allergy Drugs Advisory Committee,
     72737–72738 [E7–24812]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Dietary lipids and cancer, soy protein and coronary heart disease, antioxidant vitamins and cancers, and selenium and cancers; health claims; reevaluation,
     72738–72740 [E7–24813]   [TEXT]  [PDF]

Thursday, Dec. 20, 2007

NONE

Wednesday, Dec. 19, 2007

RULES
Human drugs:
     Vaginal contraceptive and spermicide products (OTC) containing nonoxynol 9; label requirements,
     71769–71785 [07–6111]   [TEXT]  [PDF]

NOTICES
Medical devices:
     Premarket approval applications, list; safety and effectiveness summaries availability,
     71922 [E7–24620]   [TEXT]  [PDF]

Meetings:
     Cellular, Tissue, and Gene Therapies Advisory Committee,
     71922–71923 [E7–24629]   [TEXT]  [PDF]
     Psychopharmacologic Drugs Advisory Committee,
     71923–71924 [E7–24627]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     FDA Modernization Act of 1997—
     Recognized Standards List modifications (Recognition List Number 019),
     71924–71930 [E7–24580]   [TEXT]  [PDF]

Tuesday, Dec. 18, 2007

NONE

Monday, Dec. 17, 2007

NOTICES

Reports and guidance documents; availability, etc.:
     International Conference on Harmonisation—
     Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions,
     71416–71417 [E7–24431]   [TEXT]  [PDF]
     71417–71418 [E7–24434]   [TEXT]  [PDF]
     Platelets collection by automated methods; FDA Review Staff guidance,
     71418–71419 [E7–24385]   [TEXT]  [PDF]