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GXPNews.com - FDA News and Announcements  - February 25, 2008 - February 29, 2008

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
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Federal Register - Meetings, Notices, &  Rule Changes

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 Weekly Rule Changes -
101 - 520 - 556
February 29, 2008

February 28, 2008

February 27, 2008

February 26, 2008

February 25, 2008

  • New and Generic Drug Approvals
    • Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Labeling Revision
    • Cefadroxil Oral Suspension, Lupin, Approval
    • Ciprofloxacin and Dextrose (5%) Injection, Claris Lifesciences, Tentative Approval
    • Cleocin Phosphate (clindamycin injection) Sterile Solution, Pfizer, Labeling Revision
    • Cleocin Phosphate (clindamycin in 5% dextrose) IV Sterile Solution, Pfizer, Labeling Revision
    • CORTENEMA (hydrocortisone) Rectal Suspension, ANI Pharma, Labeling Revision
    • Cosyntropin (α 1-24 corticotropin) Injection, Sandoz Inc., Approval
    • Eryc (erythromycin) Delayed-Release Capsules, Warner Chilcott, Labeling Revision
    • Lacrisert (hydroxypropyl cellulose) Ophthalmic Insert, Aton Pharma, Labeling Revision
    • RELENZA (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
    • Salonpas Pain Relief Patch, Hisamitsu Pharma, Approval
    • Vidaza (azacitidine) Injection, Pharma Corp., Manufacturing Change or Addition

CDER Drug Links

 

CBER Links

 
February 29, 2008
* Circulatory System Devices Panel Advisory Meeting, November 29-30, 2007 - Transcripts Text
* Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Agenda, Roster, Briefing Text
 
February 28, 2008
* Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements TextPDF
 
February 25, 2008
* Advice for Patients: Denture Cleansers Text
* FDA Public Health Notification: Denture Cleanser Allergic Reactions and Misuse Text
* Questions and Answers on Chattem, Inc. Icy Hot Heat Therapy Air Activated Heat (Back and Arm, Neck & Leg) Text
 


Medical Device Links

 

 

 

 

 

 

Friday, Feb. 29, 2008

RULES
 New Animal Drugs:
     Albendazole,
     11026–11027 [E8–3877]   [TEXT]  [PDF]

NOTICES
 Not Withdrawn From Sale for Reasons of Safety or Effectiveness:
     MINOCIN (Minocycline Hydrochloride) Capsules Equivalent to 75 Milligrams Base,
     11121–11122 [E8–3879]   [TEXT]  [PDF]

 Temporary Permit for Market Testing:
     Frozen Concentrate for Lemonade Deviating From Identity Standard,
     11095 [E8–3912]   [TEXT]  [PDF]
 

Thursday, Feb. 28, 2008

NONE

 

Wednesday, Feb. 27, 2008

NOTICES
 Industry Organizations Interested in Pediatric Advisory Committee Nonvoting Industry Representative Selection Process Notification Request; Nominations,
 10454–10455 [E8–3719]   [TEXT]  [PDF]

 Meetings:
     Oncologic Drugs Advisory Committee Pediatric Oncology Subcommittee,
     10455 [E8–3676]   [TEXT]  [PDF]
 

Tuesday, Feb. 26, 2008

NONE

 

Monday, Feb. 25, 2007

RULES
 Food Labeling:
     Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease,
     9938–9947 [E8–3418]   [TEXT]  [PDF]

NOTICES
 Agency Information Collection Activities; Proposals, Submissions, and Approvals,
10033–10035 [E8–3415]
Combe, Inc.; Filing of Color Additive Petition,
10035 [E8–3416]

 Guidance for Industry:
     Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products; Availability,
     10035–10036 [E8–3487]   [TEXT]  [PDF]
Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables; Availability,
10037–10038 [E8–3417]   [TEXT]  [PDF]
 

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FDA Handbooks

GMP Publications.com Code of Federal Regulations Mini-Regulation
Combination Product handbook
US GMP Training Booklet
Std. GMPs - Parts 11, 210, 211, 820 & ICH Q7
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

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