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GXPNews.com - FDA News and Announcements December 8 - December 12, 2014
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Pharmaceutical GMP GuidelinesMedical Device GuidelinesClinical GuidelinesLaboratory GuidelinesFood, Drug, and Cosmetic GuidelinesBiologics and Laboratory GuidelinesPart 11 and Computer SystemsEU, Japanese, Chinese, Spanish, ICH, and other Misc. Gudielines

> Center for Drug Evaluation & Research (CDER)
> Drug Approvals
> Meetings and Conferences
> Warning Letters
> FDA News & Events
> Biologics Evaluation & Research (CBER)
> Center for Device & Radiology Heath (CDRH)
> Federal Register -
Meetings, Notices, & Rule Changes
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>FDA and EU Regulations
Not sure what books to order?
Call 856-810-7331 and Ask for John Cuspilich, QA/RA

Whats New with CDER - Get the CDER Handbook

December 12, 2014

December 11, 2014

December 10, 2014

December 9, 2014

December 8, 2014

December 5, 2014


CDER Workshops, Meetings and Conferences

Upcoming

  • Developing and Using Precision Therapies in the “Omics" Era: Generating and Interpreting Evidence for Rare Subsets: FDA-UVA co-sponsor ship workshop, December 12, 2014, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993. Meeting information
  • Public Meeting on Chagas Disease Patient-Focused Drug Development, April 28, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD. Meeting information

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences

NONE


Whats New with CDRH

December 11, 2014

December 10, 2014

December 9, 2014

December 8, 2014

December 3, 2014


CDRH Workshops, Meetings and Conferences


Device Regulations

Electronic Systems Master Handbook 1

EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10

Medical Device QSIT Manual with 11 and 820

Medical Device QSIT Manual with 11, 803, 806, 820 and 821

Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist

Medical Device Quality Systems Manual with 820 and QSR Audit Checklist

US, EU and Canadian Medical Device Combination

US, EU and Japanese GMPs

In Vitro Diagnostics 98/79/EC Medical Devices

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

3 Day On-Site FDA/EU GMP Training Fee - International

21 CFR 4 - cGMP for Combination Products

In Vitro Diagnostics Master Handbook

GMP International Master Reference Guide

 



Weekly Rule Changes -
Wednesday - 21 CFR Part 101

Friday, December 12, 2014

NONE


Thursday, December 11, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

 

Pages 73590 - 73591 [FR DOC # 2014-29046]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program

 

Pages 73591 - 73596 [FR DOC # 2014-29064]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types

 

Pages 73596 - 73599 [FR DOC # 2014-29065]

PDF | Text

 
 

Determination That PFIZERPEN (Penicillin G Potassium) Injection, 1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 73599 - 73600 [FR DOC # 2014-29034]

PDF | Text

 
 

Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability

 

Pages 73600 - 73601 [FR DOC # 2014-29035]

PDF | Text

 

Wednesday, December 10, 2014

 

Rules and Regulations

 

Uniform Compliance Date for Food Labeling Regulations

 

Pages 73201 - 73202 [FR DOC # 2014-28829]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing

 

Pages 73320 - 73322 [FR DOC # 2014-28825]

PDF | Text

 
 

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability

 

Pages 73322 - 73323 [FR DOC # 2014-28888]

PDF | Text

 
 

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability

 

Pages 73323 - 73324 [FR DOC # 2014-28830]

PDF | Text

 
 

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting

 

Pages 73324 - 73325 [FR DOC # 2014-28881]

PDF | Text

 
 

Patient-Focused Drug Development Public Meeting on Chagas Disease

 

Pages 73325 - 73326 [FR DOC # 2014-28828]

PDF | Text

 
 

Oncologic Drugs Advisory Committee; Notice of Meeting

 

Pages 73326 - 73327 [FR DOC # 2014-28847]

PDF | Text

 
 

Request for Nominations for Voting Members on the Food Advisory Committee

 

Pages 73327 - 73328 [FR DOC # 2014-28889]

PDF | Text

 

Tuesday, December 9, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications; Correction

 

Pages 73079 - 73079 [FR DOC # 2014-28714]

PDF | Text

 
 

General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability

 

Pages 73079 - 73080 [FR DOC # 2014-28716]

PDF | Text

 
 

Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Extension of Comment Period

 

Pages 73080 - 73081 [FR DOC # 2014-28713]

PDF | Text

 
 

Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability

 

Pages 73081 - 73083 [FR DOC # 2014-28809]

PDF | Text

 
 

Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Availability

 

Pages 73083 - 73086 [FR DOC # 2014-28711]

PDF | Text

 
 

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

 

Pages 73086 - 73087 [FR DOC # 2014-28702]

PDF | Text

 

Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials

 

Pages 72687 - 72690 [FR DOC # 2014-28634]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

 

Pages 72685 - 72686 [FR DOC # 2014-28635]

PDF | Text

 
 

Request for Nominations on the Food Advisory Committee

 

Pages 72690 - 72690 [FR DOC # 2014-28652]

PDF | Text

 

Job Board

Post Jobs

  • 510(k) Submission Assistance - IVD Electronic Submission Subject Matter Experts - Assisting with the writing, and submission process for the US FDA CDRH Submission. US East Coast.
    Email resumes to info@auditing.com

 




 

End of the Year Book Sale!
Save 20% Today! Sales Code 141201

GMP International Master Reference Guide

Dietary Supplement Master Handbook

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

21 CFR 210/211 - Drug GMPs

21 CFR 820 - Quality System Regulations

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook

US, EU and Japanese GMPs

21 CFR 11, 210/211 - Electronic Records with Drug GMPs

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH

21 CFR 11, 210/211 with Keyword Index

21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs

21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH

21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

21 CFR 11, 58, 210/211, 820, ICH E6(R1) - GMP 2 Combination Handbook

21 CFR 111 - Dietary Supplement handbook

21 CFR 200, 201 - General Drug & Drug Labeling Combination

21 CFR 210/211 - Drug GMPs

21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH

21 CFR 210/211 - Drug GMPs-SPANISH

21 CFR 210/211 with Drug Preambles

21 CFR 210/211 with Keyword Index

Canadian GMP Guidelines 2009, Version 2 - Effective March 4, 2011

EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10

EU GMPs Chapter 1 - 9

EU GMPs with ICH Q7, Q8(R2), Q9 and Q10

GMP - PAT Handbook

US, EU and Japanese GMPs

Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA

ICH Q7 with Q7 Auditors Check List

3 Day On-Site FDA/EU GMP Training Bootcamp - US

ICH Q7, Q8, Q9, Q10 and Q11

3 Day On-Site FDA/EU GMP Training Fee - International

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

GMP International Master Reference Guide

21 CFR 4 - cGMP for Combination Products

21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

21 CFR 11, 58, 820 - Electronic Records with GLP and QSR

21 CFR 11, 820 - Electronic Records with Quality Systems Regulations

21 CFR 58, 820 - GLP and QSR

21 CFR 801 - Labeling - Medical Device

21 CFR 803 - Medical Device Reporting

21 CFR 806 - Medical Devices; Reports of Corrections and Removal

21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices Rev. Oct. 1, 2012

21 CFR 809 - In-Vitro Diagnostic Products

21 CFR 810 - Medical Device Recall Authority

21 CFR 812 - Investigational Device Exemptions Rev. May 30, 2012

21 CFR 814 - Premarket Approval of Medical Device

21 CFR 820 - Quality System Regulations

21 CFR 820 - Quality System Regulations-SPANISH



The Week's Drug Approvals

December 12, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Cyramza

ramucirumab

Injectable;Injection

Eli Lilly and Co

Labeling Revision

December 11, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Abraxane

paclitaxel

For Suspension;Iv (Infusion)

Abraxis Bioscience

Labeling Revision

Bloxiverz

neostigmine methylsulfate

Solution;Intravenous

Eclat Pharms Llc

Labeling Revision

Bromday

bromfenac sodium

Solution/Drops;Ophthalmic

Bausch and Lomb Inc

Manufacturing Change or Addition

Children's Motrin

ibuprofen

Suspension;Oral

Mcneil

Labeling Revision

Kalydeco

ivacaftor

Tablet;Oral

Vertex Pharms

Manufacturing Change or Addition

Linzess

linaclotide

Capsule;Oral

Forest Labs Inc

Manufacturing Change or Addition

Ovidrel

choriogonadotropin alfa

Injectable;Injection

Emd Serono

Manufacturing Change or Addition

Ovidrel

choriogonadotropin alfa

Injectable;Subcutaneous

Emd Serono

Manufacturing Change or Addition

Suboxone

buprenorphine hydrochloride; naloxone hydrochloride

Tablet;Sublingual

Reckitt Benckiser

Labeling Revision

Subutex

buprenorphine hydrochloride

Tablet;Sublingual

Reckitt Benckiser

Labeling Revision

Twynsta

amlodipine besylate; telmisartan

Tablet;Oral

Boehringer Ingelheim

Manufacturing Change or Addition

Varithena

polidocanol

Solution;Intravenous

Provensis

Manufacturing Change or Addition

Xibrom

bromfenac sodium

Solution/Drops;Ophthalmic

Bausch and Lomb Inc

Manufacturing Change or Addition

Zubsolv

buprenorphine hydrochloride; naloxone hydrochloride

Tablet;Sublingual

Orexo Ab

Manufacturing Change or Addition

December 10, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Advair Hfa

fluticasone propionate; salmeterol xinafoate

Aerosol, Metered;Inhalation

Glaxo Grp Ltd

Labeling Revision

Flovent Hfa

fluticasone propionate

Aerosol, Metered;Inhalation

Glaxo Grp Ltd

Labeling Revision

Geodon

ziprasidone hydrochloride

Capsule;Oral

Pfizer

Labeling Revision

Geodon

ziprasidone mesylate

Injectable;Intramuscular

Pfizer

Labeling Revision

Geodon

ziprasidone hydrochloride

Suspension;Oral

Pfizer Inc

Labeling Revision

Zoledronic Acid

zoledronic acid

Injectable;Iv (Infusion)

Acs Dobfar Info Sa

Labeling Revision

December 9, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Belviq

lorcaserin hydrochloride

Tablet;Oral

Eisai Inc

Labeling Revision

Extraneal

icodextrin

Solution;Intraperitoneal

Baxter Hlthcare

Labeling Revision

Onfi

clobazam

Tablet;Oral

Lundbeck Llc

Labeling Revision

Onfi

clobazam

Suspension;Oral

Lundbeck Llc

Labeling Revision

December 8, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Delflex W/ Dextrose 1.5% In Plastic Container

calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Solution;Intraperitoneal

Fresenius Medcl

Manufacturing Change or Addition

Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container

calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Solution;Intraperitoneal

Fresenius Medcl

Manufacturing Change or Addition

Delflex W/ Dextrose 2.5% In Plastic Container

calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Solution;Intraperitoneal

Fresenius Medcl

Manufacturing Change or Addition

Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container

calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Solution;Intraperitoneal

Fresenius Medcl

Manufacturing Change or Addition

Delflex W/ Dextrose 4.25% In Plastic Container

calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Solution;Intraperitoneal

Fresenius Medcl

Manufacturing Change or Addition

Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container

calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Solution;Intraperitoneal

Fresenius Medcl

Manufacturing Change or Addition

Mirena

levonorgestrel

Intrauterine Device;Intrauterine

Bayer Hlthcare

Manufacturing Change or Addition

December 5, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Abilify Maintena Kit

aripiprazole

For Suspension, Extended Release;Intramuscular

Otsuka Pharm Co Ltd

Efficacy Supplement with Clinical Data to Support

Adriamycin Pfs

doxorubicin hydrochloride

Injectable;Injection

Pharmacia and Upjohn

Manufacturing Change or Addition

Benzaclin

benzoyl peroxide; clindamycin phosphate

Gel;Topical

Valeant Bermuda

Manufacturing Change or Addition

Benzamycin

benzoyl peroxide; erythromycin

Gel;Topical

Valeant Intl

Manufacturing Change or Addition

Cardiogen-82

rubidium chloride rb-82

Injectable;Injection

Bracco

Manufacturing Change or Addition

Exparel

bupivacaine

Injectable, Liposomal;Injection

Pacira Pharms Inc

Labeling Revision

Heparin Sodium

heparin sodium

Injectable;Injection

Pfizer

Manufacturing Change or Addition

Heparin Sodium Preservative Free

heparin sodium

Injectable;Injection

Pfizer

Manufacturing Change or Addition

Klaron

sulfacetamide sodium

Lotion;Topical

Valeant Bermuda

Manufacturing Change or Addition

Minastrin 24 Fe

ethinyl estradiol; norethindrone acetate

Tablet, Chewable;Oral

Warner Chilcott Llc

Labeling Revision

Noritate

metronidazole

Cream;Topical

Valeant Bermuda

Manufacturing Change or Addition

Prolia

denosumab

Injectable; Subcutaneous

Amgen

Efficacy Supplement with Clinical Data to Support

Tricor

fenofibrate

Tablet;Oral

Abbott

Labeling Revision

Xgeva

denosumab

Injectable; Subcutaneous

Amgen

Efficacy Supplement with Clinical Data to Support


This Weeks Warning Letters:

Letter Issue Date

Company Name

Issuing Office

Subject

November 28, 2014

Hyland Acres Jerseys, Ltd

Cincinnati District Office

Illegal Drug Residue

November 24, 2014

Cau Tre Export Goods Processing Joint Stock Company

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

November 24, 2014

Cell Vitals

Center for Food Safety and Applied Nutrition

New Drug/Labeling/Misbranded

November 24, 2014

Crimasa Criaderos De Mariscos S. A.

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

November 24, 2014

Jansen Enterprises, LLC dba HealthWorksUSA

Minneapolis District Office

New Drug/Labeling/Misbranded

November 24, 2014

My Lady's Manor Farm, Inc.

Baltimore District Office

Illegal Drug Residue

November 20, 2014

Hirsch's Dairy Farm

New York District Office

Illegal Drug Residue

November 20, 2014

Long Island Pharmaceuticals LLC

New York District Office

CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

November 20, 2014

Urban Moonshine, Inc.

New England District Office

CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

November 19, 2014

Sherwood Food Distributors, LLC

Detroit District Office

Seafood HACCP/CGMP for Foods/Adulterated

November 14, 2014

Balfego and Balfego, SL

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

November 14, 2014

Hickory Smokehouse of Las Vegas, Inc.

San Francisco District Office

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

November 14, 2014

Zdenka d.d

Center for Food Safety and Applied Nutrition

Food Labeling/Misbranded