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GXPNews.com - FDA News and Announcements November 10 - November 14, 2014
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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 14, 2014

November 13, 2014

November 12, 2014

November 10, 2014

November 07, 2014


Drug Approvals

November 11, 2014

Drug Name

Sponsor

Aquasol A

Hospira

Humalog

Lilly

Humalog Kwikpen

Lilly

Humalog Pen

Lilly

Infuvite Pediatric

Sandoz

Juxtapid

Aegerion

Omtryg

Trygg

Precose

Bayer Hlthcare

November 10, 2014

Drug Name

Sponsor

Cayston

Gilead

Firmagon

Ferring

Humatrope

Lilly

Kalydeco

Vertex Pharms

Minivelle

Noven

Stivarga

Bayer Hlthcare

Tri-Luma

Galderma Labs Lp

Ventavis

Actelion Pharms Ltd

November 7, 2014

Drug Name

Sponsor

Belsomra

Merck Sharp Dohme

Foscavir

Clinigen Hlthcare

Iprivask

Marathon Pharms Llc

Otrexup

Antares Pharma Inc

Sucraid

Qol Medcl


CDER Workshops, Meetings and Conferences

Upcoming

  • 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

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 14, 2014

November 12, 2014

November 10, 2014

November 7, 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
Friday - 21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814

Friday, November 14, 2014

 

Rules and Regulations

 

Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment

 

Pages 68114 - 68116 [FR DOC # 2014-26914]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements

 

Pages 68273 - 68275 [FR DOC # 2014-26917]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient

 

Pages 68275 - 68277 [FR DOC # 2014-26998]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates

 

Pages 68277 - 68278 [FR DOC # 2014-26999]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements

 

Pages 68278 - 68280 [FR DOC # 2014-26918]

PDF | Text

 
 

Blood Products Advisory Committee; Amendment of Notice

 

Pages 68280 - 68281 [FR DOC # 2014-26969]

PDF | Text

 

Thursday, November 13, 2014

 

Notices

 

Science Board to the Food and Drug Administration Advisory Committee Meeting; Amendment of Notice

 

Pages 67438 - 67438 [FR DOC # 2014-26821]

PDF | Text

 
 

Food Advisory Committee; Notice of Meeting; Amendment of Notice

 

Pages 67438 - 67439 [FR DOC # 2014-26823]

PDF | Text

 

Wednesday, November 12, 2014

 

Proposed Rules

 

Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems

 

Pages 67105 - 67115 [FR DOC # 2014-26726]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads

 

Pages 67172 - 67174 [FR DOC # 2014-26698]

PDF | Text

 
 

DSM Nutritional Products; Food Additive Petition (Animal Use); Ethoxyquin; Environmental Assessment

 

Pages 67174 - 67174 [FR DOC # 2014-26709]

PDF | Text

 
 

Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 67175 - 67176 [FR DOC # 2014-26694]

PDF | Text

 

Tuesday, November 11, 2014

NONE


Monday, November 10, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals

 

Pages 66724 - 66728 [FR DOC # 2014-26596]

PDF | Text

 
 

Armando Santos: Debarment Order

 

Pages 66728 - 66729 [FR DOC # 2014-26562]

PDF | Text

 
 

Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

 

Pages 66729 - 66730 [FR DOC # 2014-26582]

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