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GXPNews.com - FDA News and Announcements November 24 - November 28, 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 - Get the CDER Handbook

November 28, 2014

November 26, 2014

November 25, 2014

November 24, 2014

November 21, 2014

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

November 26, 2014

November 25, 2014

November 24, 2014

November 21, 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 28, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications

 

Pages 70873 - 70875 [FR DOC # 2014-28106]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Comparing Food Safety Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers

 

Pages 70875 - 70876 [FR DOC # 2014-28088]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

 

Pages 70876 - 70878 [FR DOC # 2014-28087]

PDF | Text

 
 

The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information; Availability

 

Pages 70878 - 70879 [FR DOC # 2014-28085]

PDF | Text

 
 

Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions; Draft Guidance for Industry; Availability

 

Pages 70879 - 70880 [FR DOC # 2014-28086]

PDF | Text

 

Thursday, November 27, 2014

NONE


Wednesday, November 26, 2014

NONE


Tuesday, November 25, 2014

 

Notices

 

Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 70193 - 70194 [FR DOC # 2014-27857]

PDF | Text

 

Monday, November 24, 2014

 

Notices

 

New Clinical Trials Demographic Data; Availability for Comment

 

Pages 69863 - 69864 [FR DOC # 2014-27732]

PDF | Text

 
 

Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act; Guidance for Industry; Availability

 

Pages 69856 - 69857 [FR DOC # 2014-27692]

PDF | Text

 
 

Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance

 

Pages 69857 - 69859 [FR DOC # 2014-27691]

PDF | Text

 
 

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Final Guidance for Industry; Availability

 

Pages 69859 - 69860 [FR DOC # 2014-27693]

PDF | Text

 
 

Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments

 

Pages 69860 - 69863 [FR DOC # 2014-27713]

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

November 25, 2014

Drug Name

Sponsor

Amoxil

Dr Reddys Labs Inc

Bupropion Hydrochloride

Sandoz

Bupropion Hydrochloride

Apotex Inc

Bupropion Hydrochloride

Sun Pharma Global

Bupropion Hydrochloride

Actavis Labs Fl Inc

Bupropion Hydrochloride

Mylan

Bupropion Hydrochloride

Anchen Pharms

Bupropion Hydrochloride

Zydus Pharms Usa Inc

Bupropion Hydrochloride

Jubilant Generics

Divalproex Sodium

Reddys

Divalproex Sodium

Aurobindo Pharma Ltd

Divalproex Sodium

Aurobindo Pharma Ltd

Larotid

Dr Reddys Labs Inc

Lucentis

Genentech

Norco

Watson Labs

Priftin

Sanofi Aventis Us

Topiramate

Zydus Pharms Usa Inc

Tussicaps

Ecr Pharma

November 24, 2014

Drug Name

Sponsor

Acanya

Dow Pharm

Byetta

Astrazeneca Ab

Diclofenac Sodium

Paddock Llc

Optimark

Mallinckrodt

Optimark

Mallinckrodt

Optimark In Plastic Container

Mallinckrodt

November 21, 2014

Drug Name

Sponsor

Adcetris

Seattle Genetics

Cardizem

Valeant Intl

Hydrocodone Bitartrate and Homatropine Methylbromide

Actavis Mid Atlantic

Sensipar

Amgen

Sensipar

Amgen

Testosterone Enanthate

Hikma Farmaceutica


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

November 20, 2014

New Hope Fertility Center

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.