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GXPNews.com - FDA News and Announcements November 3 - November 7, 2014
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Drug and Device Manufacturing? 
Master FDA GMP International Reference Guide

Pharmaceutical GMP GuidelinesMedical Device GuidelinesClinical GuidelinesLaboratory GuidelinesFood, Drug, and Cosmetic GuidelinesBiologics and Laboratory GuidelinesPart 11 and Computer SystemsEU, Japanese, Chinese, Spanish, ICH, and other Misc. Gudielines

> 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?
Call 856-810-7331 and Ask for John Cuspilich, QA/RA

Whats New with CDER

November 07, 2014

November 06, 2014

November 05, 2014

November 04, 2014

November 03, 2014

October 31, 2014


Drug Approvals

November 5, 2014

Drug Name

Sponsor

Cerdelga

Genzyme Corp

Cyramza

Eli Lilly and Co

Levoxyl

King Pharms R and D

Lopid

Pfizer Pharms

Lopid

Pfizer Pharms

Olysio

Janssen Prods

Pennsaid

Mallinckrodt Inc

Protonix Iv

Wyeth Pharms Inc

Seasonale

Teva Branded Pharm

Zithromax

Pfizer

November 4, 2014

Drug Name

Sponsor

Abstral

Galena Biopharma

Docetaxel

Sandoz

Valganciclovir Hydrochloride

Endo Pharms Inc

Valganciclovir Hydrochloride

Dr Reddys Labs Ltd

November 3, 2014

Drug Name

Sponsor

Furadantin

Shionogi Inc

Kyprolis

Onyx Pharms

Levitra

Bayer Hlthcare

Lunesta

Sunovion Pharms Inc

Marqibo Kit

Talon Therap

Northera

Lundbeck Na Ltd

Telmisartan

Sandoz

October 31, 2014

Drug Name

Sponsor

Bupropion Hydrochloride

Torrent Pharms Ltd

Cyclophosphamide

Jiangsu Hengrui Med

Desonide

Taro

Fenofibrate

Ranbaxy Labs Ltd

Fluvoxamine Maleate

Torrent Pharms Ltd

Lamivudine

Silarx Pharms Inc

Levonorgestrel

Famy Care Ltd

Lexapro

Forest Labs

Lexapro

Forest Labs

Nuvaring

Organon Usa Inc

Omeprazole

Glenmark Generics

Paroxetine

Prinston Inc

Treprostinil

Sandoz Inc


CDER Workshops, Meetings and Conferences

Upcoming

  • Clinical Investigator Training Course, November 4-6, 2014, The Holiday Inn Washington, 10000 Baltimore Avenue, College Park, MD. Meeting information
  • FDA Outreach to the Pediatric Cancer Advocacy Community, November 18, 2014, FDA White Oak Campus, Bldg. 31 The Great Room A, Silver Spring, MD. Meeting information

This Weeks Warning Letters:

Letter Issue Date

Company Name

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 7, 2014

November 6, 2014

November 5, 2014

November 4, 2014

November 3, 2014

October 31, 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 7, 2014

 

Notices

 

Anti-Infective Drugs Advisory Committee; Notice of Meeting

 

Pages 66384 - 66385 [FR DOC # 2014-26442]

PDF | Text

 

Thursday, November 6, 2014

 

Proposed Rules

 

The Iams Company; Filing of Food Additive Petition (Animal Use)

 

Pages 65909 - 65910 [FR DOC # 2014-26405]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine

 

Pages 65976 - 65977 [FR DOC # 2014-26307]

PDF | Text

 
 

Specification of the Unique Facility Identifier System for Drug Establishment Registration; Guidance for Industry; Availability

 

Pages 65977 - 65978 [FR DOC # 2014-26397]

PDF | Text

 
 

Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry; Availability

 

Pages 65978 - 65979 [FR DOC # 2014-26306]

PDF | Text

 

Wednesday, November 5, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications

 

Pages 65663 - 65669 [FR DOC # 2014-26304]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers; Correction

 

Pages 65669 - 65670 [FR DOC # 2014-26238]

PDF | Text

 
 

Oncologic Drugs Advisory Committee; Notice of Meeting

 

Pages 65670 - 65671 [FR DOC # 2014-26237]

PDF | Text

 

Tuesday, November 4, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

 

Pages 65403 - 65405 [FR DOC # 2014-26140]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Food and Drug Administration-Regulated Products Used in Animals

 

Pages 65405 - 65406 [FR DOC # 2014-26141]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey

 

Pages 65406 - 65408 [FR DOC # 2014-26144]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals

 

Pages 65408 - 65409 [FR DOC # 2014-26143]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act

 

Pages 65409 - 65410 [FR DOC # 2014-26142]

PDF | Text

 
 

Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Establishment of a Public Docket

 

Pages 65410 - 65411 [FR DOC # 2014-26145]

PDF | Text

 

Monday, November 3, 2014

NONE


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