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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)
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Meetings, Notices, & Rule Changes
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>FDA and EU Regulations
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Whats New with CDER - Get the CDER Handbook

December 19, 2014

December 18, 2014

December 17, 2014

December 16, 2014

December 15, 2014

December 12, 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 19, 2014

December 18, 2014

December 16, 2014

December 15, 2014

December 11, 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 510, 520, 522 & 558

Friday, December 19, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

 

Pages 75819 - 75820 [FR DOC # 2014-29752]

PDF | Text

 
 

Minimizing Risk for Children's Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 75821 - 75822 [FR DOC # 2014-29725]

PDF | Text

 
 

Serious Drug-Induced Liver Injury: The Importance of Getting It Right: How To Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses; Public Conference; Request for Comments

 

Pages 75822 - 75822 [FR DOC # 2014-29720]

PDF | Text

 
 

Public Meeting on Patient-Focused Drug Development for Breast Cancer; Request for Comments

 

Pages 75822 - 75824 [FR DOC # 2014-29721]

PDF | Text

 

Thursday, December 18, 2014

 

Proposed Rules

 

Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products

 

Pages 75506 - 75527 [FR DOC # 2014-29522]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review

 

Pages 75564 - 75565 [FR DOC # 2014-29607]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development

 

Pages 75566 - 75568 [FR DOC # 2014-29612]

PDF | Text

 
 

Providing Regulatory Submissions in Electronic Format-Standardized Study Data; Guidance for Industry; Availability

 

Pages 75568 - 75569 [FR DOC # 2014-29608]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

 

Pages 75569 - 75570 [FR DOC # 2014-29611]

PDF | Text

 
 

Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability

 

Pages 75570 - 75572 [FR DOC # 2014-29609]

PDF | Text

 

Wednesday, December 17, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types

 

Pages 75158 - 75161 [FR DOC # 2014-29478]

PDF | Text

 

Tuesday, December 16, 2014

 

Notices

 

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

 

Pages 74730 - 74730 [FR DOC # 2014-29424]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data

 

Pages 74727 - 74728 [FR DOC # 2014-29425]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports

 

Pages 74728 - 74729 [FR DOC # 2014-29426]

PDF | Text

 
 

Crabmeat-Fresh and Frozen-Adulteration With Filth, Involving the Presence of Escherichia coli; Compliance Policy Guide; Draft Guidance for Food and Drug Administration Staff; Availability

 

Pages 74729 - 74730 [FR DOC # 2014-29314]

PDF | Text

 

Monday, December 15, 2014

 

Rules and Regulations

 

New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications

 

Pages 74018 - 74021 [FR DOC # 2014-29249]

PDF | Text

 
 

Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline

 

Pages 74021 - 74021 [FR DOC # 2014-29248]

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 18, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Afinitor

everolimus

Tablet;Oral

Novartis

Efficacy Supplement with Clinical Data to Support

Topamax

topiramate

Tablet;Oral

Janssen Pharms

Labeling Revision

Topamax

topiramate

Capsule;Oral

Janssen Pharms

Labeling Revision

Topamax Sprinkle

topiramate

Capsule;Oral

Janssen Pharms

Labeling Revision

December 17, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Boniva

ibandronate sodium

Tablet;Oral

Hoffmann La Roche

Labeling Revision

Effexor Xr

venlafaxine hydrochloride

Capsule, Extended Release;Oral

Wyeth Pharms Inc

Labeling Revision

Lotrimin Ultra

butenafine hydrochloride

Cream;Topical

Schering Plough

Efficacy Supplement with Clinical Data to Support

Qnasl

beclomethasone dipropionate

Aerosol, Metered;Nasal

Teva Branded Pharm

Efficacy Supplement with Clinical Data to Support

Stribild

cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Tablet;Oral

Gilead Sciences Inc

Efficacy Supplement with Clinical Data to Support

Xtoro

finafloxacin

Suspension/Drops;Otic

Alcon Res Ltd

Approval

December 16, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Chg Scrub

chlorhexidine gluconate

Solution;Topical

Ecolab

Manufacturing Change or Addition

Cida-Stat

chlorhexidine gluconate

Solution;Topical

Ecolab

Manufacturing Change or Addition

Diastat

diazepam

Gel;Rectal

Valeant Pharms North

Labeling Revision

Diastat Acudial

diazepam

Gel;Rectal

Valeant Pharms North

Labeling Revision

Diclegis

doxylamine succinate; pyridoxine hydrochloride

Tablet, Delayed Release;Oral

Duchesnay

Labeling Revision

Primaxin

cilastatin sodium; imipenem

Powder;Intravenous

Merck

Labeling Revision

Somatuline Depot

lanreotide acetate

Injectable;Subcutaneous

Ipsen Pharma

Supplement

Wellbutrin

bupropion hydrochloride

Tablet;Oral

Glaxosmithkline

Labeling Revision

Wellbutrin Sr

bupropion hydrochloride

Tablet, Extended Release;Oral

Glaxosmithkline

Labeling Revision

December 15, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Abilify

aripiprazole

Tablet;Oral

Otsuka

Manufacturing Change or Addition

Argatroban

argatroban

Injectable;Injection

Teva Pharms Usa Inc

Approval

Brevital Sodium

methohexital sodium

Injectable;Injection

Par Sterile Products

Manufacturing Change or Addition

Cyklokapron

tranexamic acid

Injectable;Injection

Pharmacia and Upjohn

Manufacturing Change or Addition

Egrifta

tesamorelin acetate

Powder;Subcutaneous

Theratechnologies

Manufacturing Change or Addition

Ellence

epirubicin hydrochloride

Injectable;Injection

Pfizer Inc

Labeling Revision

Exparel

bupivacaine

Injectable, Liposomal;Injection

Pacira Pharms Inc

Manufacturing Change or Addition

Firmagon

degarelix acetate

Powder;Subcutaneous

Ferring

Manufacturing Change or Addition

Intralipid 10%

soybean oil

Injectable;Injection

Fresenius

Manufacturing Change or Addition

Jakafi

ruxolitinib phosphate

Tablet;Oral

Incyte Corp

Labeling Revision

Kerydin

tavaborole

Solution;Topical

Anacor Pharms Inc

Manufacturing Change or Addition

Marcaine Hydrochloride

bupivacaine hydrochloride

Injectable;Injection

Hospira

Manufacturing Change or Addition

Marcaine Hydrochloride Preservative Free

bupivacaine hydrochloride

Injectable;Injection

Hospira

Manufacturing Change or Addition

Marcaine Hydrochloride W/ Epinephrine

bupivacaine hydrochloride; epinephrine bitartrate

Injectable;Injection

Hospira

Manufacturing Change or Addition

Marcaine Hydrochloride W/ Epinephrine Preservative Free

bupivacaine hydrochloride; epinephrine bitartrate

Injectable;Injection

Hospira

Manufacturing Change or Addition

Signifor Lar

pasireotide

Suspension; Injectable, Intramuscular

Novartis Pharms Corp

Approval

Tamiflu

oseltamivir phosphate

Capsule;Oral

Roche

Manufacturing Change or Addition

Today

nonoxynol-9

Sponge;Vaginal

Mayer Labs Inc

Manufacturing Change or Addition

Xopenex

levalbuterol hydrochloride

Solution;Inhalation

Oak Pharms Inc

Manufacturing Change or Addition

December 12, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Abilify

aripiprazole

Tablet;Oral

Otsuka

Efficacy Supplement with Clinical Data to Support

Abilify

aripiprazole

Solution;Oral

Otsuka

Efficacy Supplement with Clinical Data to Support

Abilify

aripiprazole

Tablet, Orally Disintegrating;Oral

Otsuka

Efficacy Supplement with Clinical Data to Support

Abilify

aripiprazole

Injectable;Intramuscular

Otsuka

Efficacy Supplement with Clinical Data to Support

Cyramza

ramucirumab

Injectable;Injection

Eli Lilly and Co

Labeling Revision

Ellence

epirubicin hydrochloride

Injectable;Injection

Pfizer Inc

Labeling Revision

Hetlioz

tasimelteon

Capsule;Oral

Vanda Pharms Inc

Labeling Revision

Lotensin

benazepril hydrochloride

Tablet;Oral

Us Pharms Holdings I

Labeling Revision

Lotensin Hct

benazepril hydrochloride; hydrochlorothiazide

Tablet;Oral

Us Pharms Holdings I

Labeling Revision

Micardis

telmisartan

Tablet;Oral

Boehringer Ingelheim

Labeling Revision

Micardis Hct

hydrochlorothiazide; telmisartan

Tablet;Oral

Boehringer Ingelheim

Labeling Revision

Pulmozyme

dornase alfa

Vial

Genentech

Efficacy Supplement with Clinical Data to Support

Twynsta

amlodipine besylate; telmisartan

Tablet;Oral

Boehringer Ingelheim

Labeling Revision

Tylenol

acetaminophen

Tablet, Extended Release;Oral

Mcneil Cons

Labeling Revision


This Weeks Warning Letters:

Letter Issue Date

Company Name

Issuing Office

Subject

December 16, 2014

Little Brown Smoke Shack

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 16, 2014

Midwest Service & Supply, Inc.

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 16, 2014

Northerner Scandinavia, Inc.

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 16, 2014

Peter M. Slutzky

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 16, 2014

Vivian Juarez

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 16, 2014

William Tisinger

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 08, 2014

baccycafe.com

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

December 08, 2014

Emerald Dairy, LLC and Emerald Dairy II, LLC

Minneapolis District Office

Illegal Drug Residue

December 08, 2014

Karl Storz Endovision, Inc.

New England District Office

CGMP/QSR/Medical Devices/Adulterated/Misbranded

December 08, 2014

Yandi New York Trading Co Ltd

New York District Office

Seafood HACCP/CGMP for Foods/Adulterated

December 05, 2014

Murmac Farms LLC

Philadelphia District Office

Illegal Drug Residue

December 05, 2014

Pacific Hi - Tak Inc

San Francisco District Office

Seafood HACCP/CGMP for Foods/Adulterated

December 04, 2014

DG Farms

San Francisco District Office

Illegal Drug Residue

December 03, 2014

Michael A Hatcher

Cincinnati District Office

Illegal Drug Residue

 

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