If you are having problems viewing this page, load here

GXPNews.com - FDA News and Announcements  - January 7, 2008 - January 11, 2008

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

Camstar What is the Essence of Quality Beyond CAPA

FDA.COM Information Portal and Discussion Groups

Home | New! | Drug GMPs | Clinical & Laboratory | Device & Part 11 | Food-Dietary-Cosmetic | Biologic-Cell-Blood | EU-Can-ISO-ICH-OECD-Guidance-Misc.

Stay up to date with the FDA Code of Federal Regulations changes - Enter Email Address:

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
January 11, 2008

January 10, 2008

  • Guidance for Industry (Draft): Q8(R1) Pharmaceutical Development Revision 1 [PDF]

January 9, 2008

January 8, 2008

January 7, 2008

  • FDA issues an FDA Alert and Information for Healthcare Professionals sheet for bisphosphonates. Drug Information
  • New and Generic Drug Approvals
    • Climara (estradiol) Transdermal System, Bayer HealthCare, Labeling Revision
    • EES Granules (erythromycin ethylsuccinate oral suspension) and ERY-PED Liquid, Abbott Labs, Labeling Revision
    • Ery-Ped (erythromycin ethylsuccinate) Chewable Tablets, Abbott Labs, Labeling Revision
    • Fentanyl Transdermal System, Actavis, Control Supplement
    • Granisetron Hydrochloride Injection, Teva Parenteral, Approval
    • Innopran XL (propranolol hydrochloride) Extended-Release Capsules, Reliant Pharma, Labeling Revision
    • Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Wyeth Pharma, Labeling Revision
    • Janumet (sitagliptin/metformin hydrochloride fixed-dose combination) Tablets, Merck & Co., Labeling Revision
    • Metformin Hydrochloride Extended-Release Tablets, Interpharm, Approval 
    • Nutropin AQ (somatropin [rDNA origin]) Injection, Genentech Inc., Control Supp. & Manufacturing Change or Additiion
    • Oxycodone Hydrochloride and Ibuprofen Tablets, Actavis, Approval
    • PCE (erythromycin particles) Dispertabs Tablets, Abbott Labs, Labeling Revision
    • Sular (nisoldipine) Extended-release Tablets, Sciele Pharma, Formulation Revision
    • Topiramate Tablets, Cobalt Labs, Tentative Approval

CBER Links
January 11, 2008
* Class I Medical Device Recall: Cardinal Health Alaris Infusion Pump Module (formerly Medley Pump Module), Model 8100 Text
 
January 8, 2008
* Federal Register: Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability. TextPDF
* Federal Register: Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability. TextPDF
 
January 7, 2008
* Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations TextPDF
* Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program TextPDF
 

Medical Device Links

Industry Assistance

Weekly CFR Rule
Changes - NONE

Friday, Jan. 11, 2008

PROPOSED RULES
 Requirements for Human Blood and Blood Components Intended for Transfusion or Further Manufacturing Use:
     Extension of Comment Period,
     1983 [E8–297]   [TEXT]  [PDF]

NOTICES
 Kemira Oyi; Filing of Food Additive Petition (Animal Use); Partially Ammoniated Formic Acid,
2055 [E8–316]   [TEXT]  [PDF]

 Meetings:
     Anti-Infective Drugs Advisory Committee,
     2055–2056 [E8–343]   [TEXT]  [PDF]
 

Thursday, Jan. 10, 2008

NOTICES
 International Conference on Harmonisation:
 Draft Guidance on Q8(R1) Pharmaceutical Development; Availability,
1890–1891 [E8–213]   [TEXT]  [PDF]
 

Wednesday, Jan. 9, 2008

NOTICES
 INDERAL (Propanolol Hydrochloride) Tablets, 10 Milligrams, 20 Milligrams, and 90 Milligrams Not Withdrawn from Sale for Reasons of Safety or Effectiveness;,
1619 [E8–190]   [TEXT]  [PDF]

 Memorandums of Understanding:
     Food and Drug Administration and Regents of the University of California,
     1619–1630 [08–30]   [TEXT]  [PDF]
 

Tuesday, Jan. 8, 2008

NOTICES
Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29); Withdrawal,
1357 [E8–127]