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GXPNews.com - FDA News and Announcements December 1 - December 5, 2014
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> 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
> Job Board - Post your Jobs

>FDA and EU Regulations
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Whats New with CDER - Get the CDER Handbook

December 5, 2014

December 4, 2014

December 3, 2014

December 2, 2014

December 1, 2014

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

December 8, 2014

December 3, 2014

December 2, 2014

December 1, 2014

November 26, 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 -
* Monday - 21 CFR Parts 11 & 101
* Thursday - 21 CFR Part 201

Friday, December 5, 2014

 

Notices

 

How To Obtain a Letter From the Food and Drug Administration Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategies for Reference Listed Drugs; Draft Guidance for Industry; Availability

 

Pages 72185 - 72186 [FR DOC # 2014-28540]

PDF | Text

 
 

Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications

 

Pages 72186 - 72188 [FR DOC # 2014-28541]

PDF | Text

 

* Thursday, December 4, 2014

 

Rules and Regulations

 

Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling

 

Pages 72063 - 72103 [FR DOC # 2014-28241]

PDF | Text

 
 

Notices

 

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

 

Pages 72104 - 72105 [FR DOC # 2014-28242]

PDF | Text

 

Wednesday, December 3, 2014

NONE


Tuesday, December 2, 2014

 

Notices

 

Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 71434 - 71435 [FR DOC # 2014-28267]

PDF | Text

 
 

Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability

 

Pages 71435 - 71435 [FR DOC # 2014-28256]

PDF | Text

 
 

Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 71436 - 71437 [FR DOC # 2014-28265]

PDF | Text

 
 

Establishment of a Public Docket; Electronic Cigarettes and the Public Health Workshop

 

Pages 71437 - 71437 [FR DOC # 2014-28261]

PDF | Text

 

* Monday, December 1, 2014

 

Rules and Regulations

 

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

 

Pages 71155 - 71259 [FR DOC # 2014-27833]

PDF | Text

 
 

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

 

Pages 71259 - 71293 [FR DOC # 2014-27834]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting

 

Pages 71107 - 71109 [FR DOC # 2014-28185]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program

 

Pages 71109 - 71110 [FR DOC # 2014-28184]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices

 

Pages 71110 - 71111 [FR DOC # 2014-28183]

PDF | Text

 
 

Seventh Annual Sentinel Initiative; Public Workshop; Amendment of Notice

 

Pages 71111 - 71112 [FR DOC # 2014-28196]

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 5, 2014

Drug Name

Sponsor

Submission Type

Abilify Maintena Kit

Otsuka Pharm Co Ltd

Efficacy Supplement with Clinical Data to Support

Adriamycin Pfs

Pharmacia and Upjohn

Manufacturing Change or Addition

Benzaclin

Valeant Bermuda

Manufacturing Change or Addition

Benzamycin

Valeant Intl

Manufacturing Change or Addition

Cardiogen-82

Bracco

Manufacturing Change or Addition

Exparel

Pacira Pharms Inc

Labeling Revision

Heparin Sodium

Pfizer

Manufacturing Change or Addition

Heparin Sodium Preservative Free

Pfizer

Manufacturing Change or Addition

Klaron

Valeant Bermuda

Manufacturing Change or Addition

Minastrin 24 Fe

Warner Chilcott Llc

Labeling Revision

Noritate

Valeant Bermuda

Manufacturing Change or Addition

Prolia

Amgen

Efficacy Supplement with Clinical Data to Support

Tricor

Abbott

Labeling Revision

Xgeva

Amgen

Efficacy Supplement with Clinical Data to Support

December 4, 2014

Drug Name

Sponsor

Submission Type

Acuvail

Allergan

Labeling Revision

Idamycin

Pharmacia and Upjohn

Labeling Revision

Idamycin Pfs

Pharmacia and Upjohn

Labeling Revision

Jakafi

Incyte Corp

Efficacy Supplement with Clinical Data to Support

Lastacaft

Allergan

Labeling Revision

Mozobil

Genzyme

Labeling Revision

Pamidronate Disodium

Eurohlth Intl

Labeling Revision

Vizamyl

Ge Healthcare

Labeling Revision

December 3, 2014

Drug Name

Sponsor

Submission Type

Blincyto

Amgen

Approval

Iquix

Santen

Labeling Revision

Premarin

Wyeth Pharms Inc

Labeling Revision

Quixin

Santen

Labeling Revision

Survanta

Abbvie

Manufacturing Change or Addition

Tecfidera

Biogen Idec Inc

Efficacy Supplement with Clinical Data to Support

Tecfidera

Biogen Idec Inc

Labeling Revision

Vibativ

Theravance Biopharma

Labeling Revision

December 2, 2014

Drug Name

Sponsor

Submission Type

Acephen

G and W Labs

Manufacturing Change or Addition

Actonel

Warner Chilcott Llc

Manufacturing Change or Addition

Allegra Allergy

Sanofi Aventis Us

Manufacturing Change or Addition

Allegra Hives

Sanofi Aventis Us

Manufacturing Change or Addition

Bloxiverz

Eclat Pharms Llc

Manufacturing Change or Addition

Cardene

Chiesi Usa Inc

Manufacturing Change or Addition

Cardene In 0.83% Sodium Chloride In Plastic Container

Chiesi Usa Inc

Manufacturing Change or Addition

Cardene In 0.86% Sodium Chloride In Plastic Container

Chiesi Usa Inc

Manufacturing Change or Addition

Cardene In 4.8% Dextrose In Plastic Container

Chiesi Usa Inc

Manufacturing Change or Addition

Cardene In 5.0% Dextrose In Plastic Container

Chiesi Usa Inc

Manufacturing Change or Addition

Children's Allegra Allergy

Sanofi Aventis Us

Manufacturing Change or Addition

Children's Allegra Hives

Sanofi Aventis Us

Manufacturing Change or Addition

Coumadin

Bristol Myers Squibb

Manufacturing Change or Addition

Coumadin

Bristol Myers Squibb

Manufacturing Change or Addition

Delzicol

Warner Chilcott Llc

Manufacturing Change or Addition

Docetaxel

Pfizer Labs

Manufacturing Change or Addition

Dutoprol

Covis Pharma Sarl

Manufacturing Change or Addition

Nexavar

Bayer Hlthcare

Manufacturing Change or Addition

Procysbi

Raptor Inc

Manufacturing Change or Addition

Sucraid

Qol Medcl

Manufacturing Change or Addition

Symbicort

Astrazeneca

Manufacturing Change or Addition

Targretin

Valeant Luxembourg

Manufacturing Change or Addition

Tobramycin

Pulmoflow Inc

Approval

Vpriv

Shire Human Genetic

Manufacturing Change or Addition

Vpriv

Shire Human Genetic

Manufacturing Change or Addition

December 1, 2014

Drug Name

Sponsor

Submission Type

Bimatoprost

Apotex Inc

Approval

Brisdelle

Noven Therap

Labeling Revision

Sarafem

Warner Chilcott Llc

Labeling Revision

November 26, 2014

Drug Name

Sponsor

Submission Type

Cubicin

Cubist

Labeling Revision

Mytelase

Sanofi Aventis Us

Labeling Revision

Renagel

Genzyme

Labeling Revision

Renvela

Genzyme

Labeling Revision

Renvela

Genzyme

Labeling Revision

Singulair

Merck

Labeling Revision

Singulair

Merck

Labeling Revision

Singulair

Merck

Labeling Revision

Tamiflu

Roche

Labeling Revision

Tamiflu

Roche

Labeling Revision


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

This Weeks Warning Letters:

Letter Issue Date

Company Name

Issuing Office

Subject

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