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GXPNews.com - FDA News and Announcements October 13 - October 17, 2014
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Whats New with CDER

October 17, 2014

October 16, 2014

October 15, 2014

October 14, 2014

October 10, 2014


Drug Approvals

October 16, 2014

Drug Name

Sponsor

Argatroban

Hikma Pharm Co Ltd

Cymbalta

Lilly

Fiorinal

Watson Labs Inc

Fiorinal

Watson Labs Inc

Hylenex Recombinant

Halozyme Therap

Ilaris

Novartis Pharms

Indocin

Iroko Pharms

Lialda

Shire

Megace Es

Par Pharm

Vascepa

Amarin Pharms

Xeloda

Hoffmann La Roche


October 15, 2014

Drug Name

Sponsor

Aciphex

Eisai Inc

Aciphex Sprinkle

Eisai Inc

Chantix

Pfizer Inc

Chantix

Pfizer Inc

Curosurf

Chiesi Usa Inc

Duac

Stiefel

Erivedge

Genentech

Esbriet

Intermune Inc

Istodax

Celgene

Marqibo Kit

Talon Therap

Neuraceq

Piramal Imaging

Ofev

Boehringer Ingelheim


October 14, 2014

Drug Name

Sponsor

Lymphoseek Kit

Navidea Biopharms

Tamiflu

Roche

Tamiflu

Roche

Technetium Tc 99m Generator

Ge Healthcare


October 13, 2014

Drug Name

Sponsor

Adrenaclick

Amedra Pharms

Oxycontin

Purdue Pharma Lp

Twinject 0.15

Amedra Pharms

Twinject 0.3

Amedra Pharms

Valchlor

Actelion Pharms Ltd

October 10, 2014

Drug Name

Sponsor

Akynzeo

Helsinn Hlthcare

Curosurf

Chiesi Usa Inc

Eligard

Tolmar Therap

Eligard

Tolmar Therap

Eligard

Tolmar Therap

Eligard

Tolmar Therap

Eligard

Tolmar Therap

Harvoni

Gilead Sciences Inc

Isentress

Merck Sharp Dohme

Lumason

Bracco

Naftin

Merz Pharms

Naftin

Merz Pharms

Prozac

Eli Lilly and Co

Sarafem

Eli Lilly and Co

Soliris

Alexion Pharm

Symbyax

Lilly

Verelan Pm

Alkermes Gainesville


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

October 07, 2014

Alpha Medical Instruments, LLC

October 07, 2014

Little City Dogs

October 07, 2014

Papas Dairy LLC

October 06, 2014

David T Phillips

October 06, 2014

Neely Livestock

Whats New with FDA


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 17, 2014

October 16, 2014

October 15, 2014

October 14, 2014

October 13, 2014

October 10, 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 17, 2014

 

Notices

 

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 037

 

Pages 62447 - 62449 [FR DOC # 2014-24714]

PDF | Text

 

Thursday, October 16, 2014

 

Proposed Rules

 

DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)

 

Pages 62090 - 62090 [FR DOC # 2014-24593]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment of a Tobacco User Panel

 

Pages 62160 - 62161 [FR DOC # 2014-24538]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking

 

Pages 62161 - 62163 [FR DOC # 2014-24599]

PDF | Text

 
 

New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products; Guidance for Industry; Availability

 

Pages 62163 - 62164 [FR DOC # 2014-24597]

PDF | Text

 

Wednesday, October 15, 2014

 

Notices

 

Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions

 

Pages 61872 - 61873 [FR DOC # 2014-24365]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Drug User Fee Cover Sheet

 

Pages 61873 - 61874 [FR DOC # 2014-24444]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling of Natural Rubber Latex Condoms

 

Pages 61874 - 61875 [FR DOC # 2014-24445]

PDF | Text

 
 

Distinguishing Medical Device Recalls From Medical Device Enhancements; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 61875 - 61876 [FR DOC # 2014-24446]

PDF | Text

 
 

Regulatory Science Considerations for Software Used in Diabetes Management; Public Workshop; Request for Comments

 

Pages 61876 - 61877 [FR DOC # 2014-24451]

PDF | Text

 

Tuesday, October 14, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements

 

Pages 61643 - 61644 [FR DOC # 2014-24293]

PDF | Text

 
 

Flow Cytometric Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 61644 - 61645 [FR DOC # 2014-24308]

PDF | Text

 
 

Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop

 

Pages 61645 - 61646 [FR DOC # 2014-24307]

PDF | Text

 

Monday, October 13, 2014

NONE


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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