Sign up Today!
GXPNews.com - FDA News and Announcements October 06 - October 10, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
  3 day on-site GMP Mock FDA Audit  
GMP / Mock FDA 3 day all inclusive on-site Audit - $5,995.00
Drug and Device Manufacturing?  Get the 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

>FDA and EU Regulations
Not sure what books to order?
Ask for John Cuspilich, QA/RA

Whats New with CDER

October 10, 2014

October 9, 2014

October 8, 2014

October 7, 2014

October 6, 2014

October 3, 2014


Drug Approvals

October 10, 2014

Drug Name

Sponsor

Akynzeo

Helsinn Hlthcare

October 9, 2014

Drug Name

Sponsor

Pegintron

Schering

Pegintron

Schering

Sylatron

Schering

Verelan

Alkermes Gainesville

October 8, 2014

Drug Name

Sponsor

Eurax

Ranbaxy

Olopatadine Hydrochloride

Apotex Inc

Otrexup

Antares Pharma Inc

Tamiflu

Roche

Velcade

Millennium Pharms

October 7, 2014

Drug Name

Sponsor

Ambien

Sanofi Aventis Us

Ambien Cr

Sanofi Aventis Us

Benicar

Daiichi Sankyo

Budesonide

Salix Pharms

Darunavir Ethanolate

Hetero Labs Unit Iii

Lo Minastrin Fe

Warner Chilcott

Otrexup

Antares Pharma Inc

Torisel

Pf Prism Cv

Zoladex

Astrazeneca

Zoladex

Astrazeneca

October 6, 2014

Drug Name

Sponsor

Calcium Acetate

Amneal Pharms

Eylea

Regeneron Pharmaceuticals

Orenitram

United Therap

October 3, 2014

Drug Name

Sponsor

Cortifoam

Meda Pharms

Flo-Pred

Taro

Nexium 24hr

Astrazeneca Lp


CDER Workshops, Meetings and Conferences

Upcoming

  • FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814. Meeting information
  • The FDA, the Critical Path Institute (C-Path) and the Burroughs Wellcome Fund (BWF) are co-sponsoring the “First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates” – October 28 and 29, 2014 – FDA White Oak Campus – Great Room 1503 A. We would like to invite you all to participate in this workshop on October 28 and 29, 2014. Meeting Information
  • Development and Regulation of Abuse-Deterrent Opioid Medications; Public Meeting, October 30-31, 2014, Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. Meeting information
  •  Clinical Investigator Training Course, November 4-6, 2014, The Holiday Inn Washington, 10000 Baltimore Avenue, College Park, MD. Meeting information

This Weeks Warning Letters:

Letter Issue Date

Company Name

September 30, 2014

cigarettes-ez-store.com

September 30, 2014

smokin4free.com@iprivacyltd.com

September 30, 2014

www.200discount-cigarettes.com

September 30, 2014

www.cheap-discount-cigarettes-online.net

September 29, 2014

George Katsafados Ltd.

September 29, 2014

http://www.onlythebest4u.info

September 29, 2014

www.1cigarettesonline.net

September 29, 2014

www.bestcigigarettesonline.com

September 29, 2014

www.cigarettes.co

September 26, 2014

Ambco Electronics, A California Corp

September 26, 2014

Hospira Australia Pty Ltd.

September 26, 2014

http://www.smokeandshop.com

September 26, 2014

Intershell International Corp.

September 26, 2014

Nova Products, Inc.

September 25, 2014

http://www.dirtcheapbutts.com

September 25, 2014

Multimmunity, Inc.

September 25, 2014

www.tobaccogeneral.com

Whats New with FDA

October 2014


Whats New with CBER


CBER Workshops, Meetings and Conferences

FDA Industry Meeting: Electronic Postmarket Safety Reporting Updates
October 27, 2014; FDA White Oak Campus - Silver Spring, MD


Whats New with CDRH

October 10, 2014

October 9, 2014

October 8, 2014

October 7, 2014

October 6, 2014

October 3, 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, October 10, 2014

NONE


Thursday, October 9, 2014

  Notices
  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL30); Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms; Availability
  Pages 61081 - 61082 [FR DOC # 2014-24152] PDF | Text | More
 
  Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
  Pages 61082 - 61083 [FR DOC # 2014-24039] PDF | Text | More
 
  Oncologic Drugs Advisory Committee; Notice of Meeting
  Pages 61083 - 61083 [FR DOC # 2014-24038] PDF | Text | More
 
  Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee
  Pages 61083 - 61084 [FR DOC # 2014-24074] PDF | Text | More
 

Wednesday, October 8, 2014

  Notices
  Prescription Drug User Fee Act Patient-Focused Drug Development; Request for Comments
  Pages 60857 - 60859 [FR DOC # 2014-23965] PDF | Text | More
 
  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
  Pages 60851 - 60851 [FR DOC # 2014-24051] PDF | Text | More
 
  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
  Pages 60851 - 60851 [FR DOC # 2014-23956] PDF | Text | More
 
  Determination That LUPRON DEPOT (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
  Pages 60852 - 60852 [FR DOC # 2014-23961] PDF | Text | More
 
  Critical Path Innovation Meetings; Draft Guidance for Industry; Availability
  Pages 60852 - 60853 [FR DOC # 2014-23970] PDF | Text | More
 
  The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability
  Pages 60853 - 60854 [FR DOC # 2014-23972] PDF | Text | More
 
  Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen; Draft Guidance for Industry; Availability
  Pages 60854 - 60855 [FR DOC # 2014-23973] PDF | Text | More
 
  Drug Safety and Risk Management Advisory Committee; Notice of Meeting
  Pages 60856 - 60856 [FR DOC # 2014-24002] PDF | Text | More
 
  Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
  Pages 60856 - 60857 [FR DOC # 2014-24001] PDF | Text | More
 

Tuesday, October 7, 2014

  Notices
  Laboratory Site Tours Program
  Pages 60477 - 60478 [FR DOC # 2014-23844] PDF | Text | More
 
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation
  Pages 60474 - 60476 [FR DOC # 2014-23846] PDF | Text | More
 
  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
  Pages 60476 - 60476 [FR DOC # 2014-23842] PDF | Text | More
 
  Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; Guidance for Industry; Availability
  Pages 60476 - 60477 [FR DOC # 2014-23845] PDF | Text | More
 

Monday, October 6, 2014

NONE



 

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