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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
Not sure what books to order?
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Whats New with CDER - Get the CDER Handbook

December 24, 2014

December 23, 2014

December 22, 2014

December 19, 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 24, 2014

December 22, 2014

December 19, 2014

December 18, 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 Parts 172 & 860

Thursday - 21 CFR Part 316

Friday, December 26, 2014

NONE


Thursday, December 25, 2014

NONE


Wednesday, December 24, 2014

 

Rules and Regulations

 

Food Additives Permitted for Direct Addition to Food for Human Consumption; Advantame

 

Pages 77385 - 77387 [FR DOC # 2014-30144]

PDF | Text

 
 

Medical Device Classification Procedures; Reclassification Petition: Content and Form; Technical Amendment

 

Pages 77387 - 77388 [FR DOC # 2014-30141]

PDF | Text

 
 

Proposed Rules

 

Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Availability

 

Pages 77414 - 77415 [FR DOC # 2014-30142]

PDF | Text

 
 

Notices

 

Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus; Availability

 

Pages 77500 - 77515 [FR DOC # 2014-30108]

PDF | Text

 
 

Rare Pediatric Disease Priority Review Vouchers; Extension of Comment Period

 

Pages 77498 - 77498 [FR DOC # 2014-30154]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive

 

Pages 77498 - 77500 [FR DOC # 2014-30157]

PDF | Text

 
 

Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability

 

Pages 77515 - 77516 [FR DOC # 2014-30109]

PDF | Text

 
 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 77516 - 77516 [FR DOC # 2014-30149]

PDF | Text

 


Tuesday, December 23, 2014

 

Rules and Regulations

 

Policy on Orphan-Drug Exclusivity; Clarification

 

Pages 76888 - 76888 [FR DOC # 2014-29920]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

 

Pages 77010 - 77011 [FR DOC # 2014-29917]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption From Preemption

 

Pages 77011 - 77011 [FR DOC # 2014-30012]

PDF | Text

 
 

Compliance Policy Guide Sec. 540.700 Labeling of Processed and Blended Seafood Products Made Primarily With Fish Protein; Availability

 

Pages 77011 - 77012 [FR DOC # 2014-30015]

PDF | Text

 
 

Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 77012 - 77013 [FR DOC # 2014-30011]

PDF | Text

 
 

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration: Guidance for Industry; Availability

 

Pages 77013 - 77014 [FR DOC # 2014-29988]

PDF | Text

 

Monday, December 22, 2014

 

Notices

 

Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 76331 - 76333 [FR DOC # 2014-29832]

PDF | Text

 
 

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

 

Pages 76333 - 76333 [FR DOC # 2014-29860]

PDF | Text

 
 

Independent Assessment of the Process for the Review of Device Submissions; Final Implementation Plan

 

Pages 76333 - 76334 [FR DOC # 2014-29800]

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 22, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Cordarone

amiodarone hydrochloride

Tablet;Oral

Wyeth Pharms Inc

Labeling Revision

Dextrose 10% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 20% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 30% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 40% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 5% and Potassium Chloride 0.075% In Plastic Container

dextrose; potassium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 5% and Potassium Chloride 0.15% In Plastic Container

dextrose; potassium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 5% and Potassium Chloride 0.224% In Plastic Container

dextrose; potassium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 5% and Potassium Chloride 0.3% In Plastic Container

dextrose; potassium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 5% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 50% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 50% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 60% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 60% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 70% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Dextrose 70% In Plastic Container

dextrose

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Extavia

interferon beta-1b

Injectable; Subcutaneous

Novartis Pharms

Labeling Revision

Opdivo

nivolumab

Injectable;Injection

Bristol Myers Squibb

Approval

Plasma-Lyte 56 and Dextrose 5% In Plastic Container

dextrose; magnesium acetate tetrahydrate; potassium acetate; sodium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Potassium Chloride

potassium chloride

Solution; Oral

Pharma-Med Inc

Approval

Remodulin

treprostinil

Injectable;Iv (Infusion), Subcutaneous

United Therap

Labeling Revision

Sodium Chloride 0.45% In Plastic Container

sodium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Sodium Chloride 0.9% In Plastic Container

sodium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Sodium Chloride 3% In Plastic Container

sodium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Sodium Chloride 5% In Plastic Container

sodium chloride

Injectable;Injection

Baxter Hlthcare

Labeling Revision

Somatuline Depot

lanreotide acetate

Injectable;Subcutaneous

Ipsen Pharma

Labeling Revision

Tykerb

lapatinib ditosylate

Tablet;Oral

Smithkline Beecham

Labeling Revision

December 19, 2014

Drug Name

Active Ingredient

Dosage Form/Route

Sponsor

Submission Type

Acetazolamide Sodium

acetazolamide sodium

Injectable;Injection

Emcure Pharms Ltd

Approval

Aciphex

rabeprazole sodium

Tablet, Delayed Release;Oral

Eisai Inc

Labeling Revision

Aciphex Sprinkle

rabeprazole sodium

Capsule, Delayed Release;Oral

Eisai Inc

Labeling Revision

Camptosar

irinotecan hydrochloride

Injectable;Injection

Pfizer Inc

Labeling Revision

Clozaril

clozapine

Tablet;Oral

Novartis

Labeling Revision

Cutivate

fluticasone propionate

Lotion;Topical

Fougera Pharms

Manufacturing Change or Addition

Dexilant

dexlansoprazole

Capsule, Delayed Release;Oral

Takeda Pharms Usa

Labeling Revision

Erwinaze

asparaginase erwinia chrysanthemi

Injectable; Injection

Eusa Pharma Usa

Labeling Revision

Esomeprazole Strontium

esomeprazole strontium

Capsule, Delayed Release;Oral

Hanmi Pharm Co Ltd

Labeling Revision

Estradiol

estradiol

Film, Extended Release;Transdermal

Mylan Technologies

Approval

Ganirelix Acetate

ganirelix acetate

Injectable;Injection

Organon Usa Inc

Labeling Revision

Halaven

eribulin mesylate

Solution;Intravenous

Eisai Inc

Labeling Revision

Lynparza

olaparib

Capsule; Oral

Astrazeneca Lp

Approval

Merrem

meropenem

Injectable;Injection

Astrazeneca

Labeling Revision

Nexium

esomeprazole magnesium

Capsule, Delayed Rel Pellets;Oral

Astrazeneca

Labeling Revision

Nexium

esomeprazole magnesium

For Suspension, Delayed Release;Oral

Astrazeneca

Labeling Revision

Nexium

esomeprazole magnesium

For Suspension, Delayed Release;Oral

Astrazeneca

Labeling Revision

Nexium Iv

esomeprazole sodium

Injectable;Intravenous

Astrazeneca

Labeling Revision

Prevacid

lansoprazole

Capsule, Delayed Rel Pellets;Oral

Takeda Pharms Usa

Labeling Revision

Prevacid

lansoprazole

Tablet, Delayed Release, Orally Disintegrating;Oral

Takeda Pharms Usa

Labeling Revision

Prevpac

amoxicillin; clarithromycin; lansoprazole

Capsule, Capsule, Delayed Rel Pellets, Tablet;Oral

Takeda Pharms Usa

Labeling Revision

Prilosec

omeprazole

Capsule, Delayed Rel Pellets;Oral

Astrazeneca

Labeling Revision

Prilosec

omeprazole magnesium

For Suspension, Delayed Release;Oral

Astrazeneca

Labeling Revision

Protonix

pantoprazole sodium

Tablet, Delayed Release;Oral

Wyeth Pharms Inc

Labeling Revision

Protonix

pantoprazole sodium

For Suspension, Delayed Release;Oral

Wyeth Pharms Inc

Labeling Revision

Protonix Iv

pantoprazole sodium

Injectable;Iv (Infusion)

Wyeth Pharms Inc

Labeling Revision

Rapivab

peramivir

Injectable;Iv (Infusion)

Biocryst Pharmaceuticals Inc

Approval

Simponi

golimumab

Injectable; Injection

Centocor Ortho Biotech Inc

Labeling Revision

Simponi Aria

golimumab

Injectable; Injection

Janssen Biotech

Labeling Revision

Soolantra

ivermectin

Cream;Topical

Galderma Res and Dev Llc

Approval

Sutent

sunitinib malate

Capsule;Oral

Cppi Cv

Labeling Revision

Symbyax

fluoxetine hydrochloride; olanzapine

Capsule;Oral

Lilly

Labeling Revision

Tbo-Filgrastim

tbo-filgrastim

Injectable; Injection

Sicor Biotech

Labeling Revision

Tivicay

dolutegravir sodium

Tablet;Oral

Viiv Hlthcare

Labeling Revision

Trulicity

dulaglutide

Injectable;Injection

Eli Lilly and Co

Labeling Revision

Ventolin Hfa

albuterol sulfate

Aerosol, Metered;Inhalation

Glaxosmithkline

Labeling Revision

Viekira Pak

ombitasivr; paritaprevir; ritonavir; dasabuvir

Tablet, Tablet;Oral

Abbvie Inc

Approval

Vimovo

esomeprazole magnesium; naproxen

Tablet, Delayed Release;Oral

Horizon Pharma

Labeling Revision

Xarelto

rivaroxaban

Tablet;Oral

Janssen Pharms

Labeling Revision

Zegerid

omeprazole; sodium bicarbonate

For Suspension;Oral

Santarus Inc

Labeling Revision

Zegerid

omeprazole; sodium bicarbonate

Capsule;Oral

Santarus Inc

Labeling Revision

Zerbaxa

ceftolozane;tazobactam

Injectable;Injection

Cubist Pharms Inc

Approval

Zyprexa

olanzapine

Tablet;Oral

Lilly

Labeling Revision

Zyprexa

olanzapine

Injectable;Intramuscular

Lilly

Labeling Revision

Zyprexa Relprevv

olanzapine pamoate

Suspension, Extended Release;Intramuscular

Eli Lilly Co

Labeling Revision

Zyprexa Zydis

olanzapine

Tablet, Orally Disintegrating;Oral

Lilly

Labeling Revision

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

Ammonia N-13

ammonia n 13

Injectable;Intravenous

Wi Medcl Cyclotron

Approval

Bupropion Hydrochloride

bupropion hydrochloride

Tablet, Extended Release;Oral

Sun Pharma Global

Approval

Fludeoxyglucose F18

fludeoxyglucose f-18

Injectable;Intravenous

Shertech Labs Llc

Approval

Lamivudine

lamivudine

Tablet;Oral

Lupin Ltd

Approval

Magnesium Sulfate

magnesium sulfate

Injectable;Injection

Exela Pharma Scs Llc

Approval

Oxycodone Hydrochloride and Acetaminophen

acetaminophen; oxycodone hydrochloride

Solution;Oral

Vintage Pharms

Approval

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


Recent Warning Letters:

Letter Issue Date

Company Name

Issuing Office

Subject

December 15, 2014

Gerratt Dairy

Seattle District Office

Illegal Drug Residue Animal Tissue/Adulterated

December 09, 2014

NYWP Enterprise LLC.

Philadelphia District Office

CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions

December 09, 2014

Delta Pharma, Inc.

New Orleans District Office

CGMP/Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

December 09, 2014

Sagemax Bioceramics, Inc.

Seattle District Office

CGMP/QSR/Medical Devices/Adulterated/Misbranded

December 04, 2014

Maquet Cardiopulmonary Ag

Center for Devices and Radiological Health

Premarket Approval/Misbranded/Adulterated