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GXPNews.com - FDA News and Announcements November 17 - November 21, 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)
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Meetings, Notices, & Rule Changes
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>FDA and EU Regulations
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Whats New with CDER

November 21, 2014

November 20, 2014

November 19, 2014

November 18, 2014

November 17, 2014

November 14, 2014


The Week's Drug Approvals

November 20, 2014

Drug Name

Sponsor

Aleve Pm

Bayer Hlthcare

Avelox

Bayer Hlthcare

Avelox In Sodium Chloride 0.8% In Plastic Container

Bayer Hlthcare

Biltricide

Bayer Hlthcare

Carac

Valeant Bermuda

Dalvance

Durata Theraps Intl

Depacon

Abbvie

Depakene

Abbvie

Depakene

Abbvie

Depakote

Abbvie

Depakote

Abbvie

Depakote Er

Abbvie

Finasteride

Cipla Ltd

Gliadel

Arbor Pharms Llc

Hysingla Er

Purdue Pharma

Isordil

Valeant Bermuda

Jenloga

Concordia Pharms Inc

Kapvay

Concordia Pharms Inc

Locoid Lipocream

Precision Dermat

Priftin

Sanofi Aventis Us

Stendra

Vivus

November 19, 2014

Drug Name

Sponsor

Avelox

Bayer Hlthcare

Creon

Abbvie

Drospirenone and Ethinyl Estradiol

Novast Labs Ltd

Intuniv

Shire

Jevtana Kit

Sanofi Aventis Us

Lioresal

Medtronic Neuro

Tobi Podhaler

Novartis

November 18, 2014

Drug Name

Sponsor

Children's Fexofenadine Hydrochloride Allergy

Actavis Mid Atlantic

Children's Fexofenadine Hydrochloride Hives

Actavis Mid Atlantic

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Dr Reddys Labs Ltd

Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride

Dr Reddys Labs Ltd

Paricalcitol

Hikma

Saphris

Forest Labs Inc

Votrient

Glaxosmithkline

November 17, 2014

Drug Name

Sponsor

Cutivate

Fougera Pharms

Hepatamine 8%

B Braun

Nucynta

Janssen Pharms

Pegintron

Schering

Pegintron

Schering

Sylatron

Schering

Unasyn

Pfizer

November 16, 2014

Drug Name

Sponsor

Choline C-11

Mcprf

Fiorinal W/Codeine

Watson Labs Inc

Injectafer

Luitpold

Morphine Sulfate

Bd Rx

Resectisol In Plastic Container

B Braun

Zytiga

Janssen Biotech

November 15, 2014

Drug Name

Sponsor

Ferric Citrate

Keryx Biopharms

November 14, 2014

Drug Name

Sponsor

Androgel

Abbvie

Androgel

Abbvie

Avastin

Genentech

Campath

Ilex Pharmaceuticals

Flovent Hfa

Glaxo Grp Ltd

Fycompa

Eisai Inc

Obredon

Sovereign Pharma Llc

Omniscan

Ge Healthcare

Precedex

Hospira

Precedex

Hospira

Sovaldi

Gilead Sciences Inc

Taxotere

Sanofi Aventis Us

Tecfidera

Biogen Idec Inc

Vyvanse

Shire Development


CDER Workshops, Meetings and Conferences

Upcoming

  • 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

November 19, 2014

LifeSilver

November 18, 2014

Bodyhealth.com, LLC

November 18, 2014

Ebola-C Inc

November 12, 2014

El-Vi Farms, LLC

November 12, 2014

K.I.Z. FOODS LIMITED

November 12, 2014

Reuben R. Zimmerman

November 10, 2014

Wells Pharmacy Network LLC

November 07, 2014

Kelly Hills Dairy Inc

November 06, 2014

Noel D. Elmore

November 06, 2014

Vella Cheese Company of California Inc.

November 05, 2014

Valley Foods Inc

November 03, 2014

Sixdog Investments, LLC

November 03, 2014

Vietti Acquisitions, LLC

October 30, 2014

King Mountain Tobacco Company, Inc.

October 29, 2014

Horse Gold, Inc

October 29, 2014

HorsePreRace

October 29, 2014

International Marine Products, Inc.

October 29, 2014

Tri-Star Equine

October 28, 2014

Xanacare Technologies, LLC

October 23, 2014

Canine Care

October 21, 2014

Hikma Farmaceutica, (Portugal) S.A.

October 17, 2014

Golden Pride, Inc.

October 17, 2014

Old Mill Bread Company

October 17, 2014

Vitamins Direct (USA), Inc.

October 21, 2014

DNG Trading & Milling, LLC

October 16, 2014

Vitalab Co Inc

October 15, 2014

Citrus Fit

October 15, 2014

Health & Herbs

October 10, 2014

IL Pastaio, Inc.

October 10, 2014

Mills Dairy Farm LLC

October 10, 2014

Western/Scott Fetzer Company

October 09, 2014

Bethel Nutritional Consulting, Inc

October 09, 2014

Minerva Dairy Inc

October 09, 2014

Rex L. Jessee

October 08, 2014

Prospect Enterprises, Inc.

October 07, 2014

YoungYou International Inc

September 30, 2014

Stoney Hill Farms

September 26, 2014

http://www.buydiscountcigars.com

September 24, 2014

Beacon Hill Medical Pharmacy, P.C.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences

NONE


Whats New with CDRH

November 21, 2014

November 20, 2014

November 19, 2014

November 17, 2014

November 14, 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, November 21, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed

 

Pages 69493 - 69494 [FR DOC # 2014-27518]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body

 

Pages 69494 - 69496 [FR DOC # 2014-27517]

PDF | Text

 
 

Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability

 

Pages 69496 - 69497 [FR DOC # 2014-27521]

PDF | Text

 
 

Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction

 

Pages 69497 - 69497 [FR DOC # 2014-27522]

PDF | Text

 
 

Developing and Using Precision Therapies in the “Omics” Era: Generating and Interpreting Evidence for Rare Subsets; Public Workshop

 

Pages 69497 - 69498 [FR DOC # 2014-27523]

PDF | Text

 
 

Anti-Infective Drugs Advisory Committee; Notice of Meeting

 

Pages 69498 - 69498 [FR DOC # 2014-27573]

PDF | Text

 

Thursday, November 20, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Risk and Benefit Perception Scale Development

 

Pages 69121 - 69124 [FR DOC # 2014-27431]

PDF | Text

 

Wednesday, November 19, 2014

 

Proposed Rules

 

Questions and Answers Regarding Food Facility Registration (Sixth Edition); Guidance for Industry; Availability

 

Pages 68810 - 68812 [FR DOC # 2014-27290]

PDF | Text

 
 

Notices

 

Proposed Criteria for “First Generic” Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments; Establishment of a Public Docket

 

Pages 68891 - 68892 [FR DOC # 2014-27385]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products

 

Pages 68888 - 68890 [FR DOC # 2014-27283]

PDF | Text

 
 

Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability

 

Pages 68890 - 68890 [FR DOC # 2014-27384]

PDF | Text

 
 

Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Guidance for Industry; Availability

 

Pages 68890 - 68891 [FR DOC # 2014-27287]

PDF | Text

 

Tuesday, November 18, 2014

NONE


Monday, November 17, 2014

 

Proposed Rules

 

Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness; Correction

 

Pages 68395 - 68395 [FR DOC # 2014-27038]

PDF | Text

 
 

Notices

 

Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry; Availability

 

Pages 68451 - 68454 [FR DOC # 2014-27022]

PDF | Text

 
 

Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14 New Drug Applications

 

Pages 68454 - 68455 [FR DOC # 2014-27039]

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