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Whats New with CDER - Get the CDER Handbook

January 2, 2015

December 31, 2014

December 30, 2014

December 29, 2014

 


CDER Workshops, Meetings and Conferences

Upcoming

  • Public Meeting on Breast Cancer Patient-Focused Drug Development, April 2, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD. 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 31, 2014

December 30, 2014

December 29, 2014

December 24, 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 - NONE

Friday, January 2, 2015

NONE


Thursday, January 1, 2015

NONE


Wednesday, December 31, 2014

 

Proposed Rules

 

Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products

 

Pages 78744 - 78749 [FR DOC # 2014-30528]

PDF | Text

 
 

Notices

 

The Drug Supply Chain Security Act Implementation: Product Tracing Requirements-Compliance Policy; Guidance for Industry; Availability

 

Pages 78874 - 78875 [FR DOC # 2014-30608]

PDF | Text

 


Tuesday, December 30, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

 

Pages 78443 - 78444 [FR DOC # 2014-30452]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

 

Pages 78444 - 78445 [FR DOC # 2014-30513]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

 

Pages 78445 - 78446 [FR DOC # 2014-30511]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Recall Regulations

 

Pages 78446 - 78447 [FR DOC # 2014-30461]

PDF | Text

 
 

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

 

Pages 78447 - 78448 [FR DOC # 2014-30514]

PDF | Text

 
 

Advisory Committees; Filing of Closed Meeting Reports

 

Pages 78448 - 78448 [FR DOC # 2014-30460]

PDF | Text

 
 

Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 78448 - 78449 [FR DOC # 2014-30453]

PDF | Text

 
 

Science Board to the Food and Drug Administration; Notice of Meeting

 

Pages 78449 - 78450 [FR DOC # 2014-30516]

PDF | Text

 
 

Electronic Cigarettes and the Public Health; Public Workshop

 

Pages 78450 - 78452 [FR DOC # 2014-30450]

PDF | Text

 

Monday, December 29, 2014

 

Notices

 

Next Generation Sequencing Diagnostic Tests; Public Workshop; Request for Comments

 

Pages 78092 - 78093 [FR DOC # 2014-30308]

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

 




 

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 31, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Lotrel

amlodipine besylate; benazepril hydrochloride

Capsule;Oral

Novartis

Labeling Revision

December 30, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Aplenzin

bupropion hydrobromide

Tablet, Extended Release;Oral

Valeant Bermuda

Labeling Revision

Lamictal

lamotrigine

Tablet;Oral

Glaxosmithkline Llc

Labeling Revision

Lamictal Cd

lamotrigine

Tablet, Chewable;Oral

Glaxosmithkline Llc

Labeling Revision

Lamictal Odt

lamotrigine

Tablet, Orally Disintegrating;Oral

Glaxosmithkline Llc

Labeling Revision

Lamictal Xr

lamotrigine

Tablet, Extended Release;Oral

Glaxosmithkline Llc

Labeling Revision

Natroba

spinosad

Suspension;Topical

Parapro Llc

Efficacy Supplement with Clinical Data to Support

Orencia

abatacept

Injectable; Iv (Infusion)

Bristol Myers Squibb

Labeling Revision

Wellbutrin Xl

bupropion hydrochloride

Tablet, Extended Release;Oral

Valeant Intl

Labeling Revision

December 29, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Gadavist

gadobutrol

Solution;Intravenous

Bayer Hlthcare

Efficacy Supplement with Clinical Data to Support

Inlyta

axitinib

Tablet;Oral

Pfizer

Labeling Revision

Kalydeco

ivacaftor

Tablet;Oral

Vertex Pharms

Efficacy Supplement with Clinical Data to Support

Kalydeco

ivacaftor

Tablet;Oral

Vertex Pharms

Labeling Revision

Omeprazole and Clarithromycin and Amoxicillin

amoxicillin; clarithromycin; omeprazole

Capsule, Tablet, Capsule, Delayed Release;Oral

Gastroentero

Labeling Revision

December 24, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Abstral

fentanyl citrate

Tablet;Sublingual

Galena Biopharma

Supplement

Actiq

fentanyl citrate

Troche/Lozenge;Transmucosal

Cephalon

Supplement

Capoten

captopril

Tablet;Oral

Par Pharm

Labeling Revision

Fentora

fentanyl citrate

Tablet;Buccal, Sublingual

Cephalon

Supplement

Gazyva

obinutuzumab

Injectable;Injection

Genentech

Efficacy Supplement with Clinical Data to Support

Lazanda

fentanyl citrate

Spray, Metered;Nasal

Depomed Inc

Labeling Revision

Lazanda

fentanyl citrate

Spray, Metered;Nasal

Depomed Inc

Supplement

Lotrel

amlodipine besylate; benazepril hydrochloride

Capsule;Oral

Novartis

Labeling Revision

Mavik

trandolapril

Tablet;Oral

Abbvie

Labeling Revision

Onsolis

fentanyl citrate

Film;Buccal

Meda Pharms

Supplement

Subsys

fentanyl

Spray;Sublingual

Insys Therap

Labeling Revision

Subsys

fentanyl

Spray;Sublingual

Insys Therap

Manufacturing Change or Addition

Subsys

fentanyl

Spray;Sublingual

Insys Therap

Supplement

Tarka

trandolapril; verapamil hydrochloride

Tablet, Extended Release;Oral

Abbvie

Labeling Revision

Vaseretic

enalapril maleate; hydrochlorothiazide

Tablet;Oral

Valeant Intl

Labeling Revision

Vasotec

enalapril maleate

Tablet;Oral

Valeant Intl

Labeling Revision

Zestoretic

hydrochlorothiazide; lisinopril

Tablet;Oral

Astrazeneca

Labeling Revision

Zestril

lisinopril

Tablet;Oral

Astrazeneca

Labeling Revision

Zyban

bupropion hydrochloride

Tablet, Extended Release;Oral

Glaxosmithkline

Labeling Revision


Recent Warning Letters:

Letter Issue Date

Company Name

Issuing Office

Subject

December 22, 2014

marcigs.com

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 19, 2014

Novacyl Wuxi Pharmaceutical Co., Ltd.

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Active Pharmaceutical Ingredient(API)/Adulterated

December 18, 2014

Wellmill LLC/DBA Vitamix Laboratories

New York District Office

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

December 18, 2014

Wild Edibles Inc.

New York District Office

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

December 17, 2014

Dandy Day Corporation

Denver District Office

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

November 24, 2014

Sociedad Guidomar Ltda

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated

October 15, 2014

DIMA S.L.

Center for Devices and Radiological Health

Medical Devices/Adulterated/Quality System Regulation (QSR)

October 02, 2014

Sunsweet Growers

Center for Food Safety and Applied Nutrition

Food Labeling/Misbranded

September 23, 2014

Mayfair Medical Supplies Ltd

Center for Devices and Radiological Health

Medical Devices/Adulterated/Quality System Regulation (QSR)

September 11, 2014

LockDown Medical Ltd.

Center for Devices and Radiological Health

Medical Devices/Adulterated/Quality System Regulation (QSR)

September 11, 2014

MedX Health Corp

Center for Devices and Radiological Health

Medical Devices/Adulterated/Quality System Regulation (QSR)