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GXPNews.com - FDA News and Announcements September 15 - September 19, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
   
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> Center for Drug Evaluation & Research (CDER)
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Whats New with CDER

September 19, 2014

September 18, 2014

September 17, 2014


Drug Approvals

September 18, 2014

Drug Name

Sponsor

Aloxi

Helsinn Hlthcare

Aloxi

Helsinn Hlthcare

Anzemet

Sanofi Aventis Us

Anzemet

Sanofi Aventis Us

Biltricide

Bayer Hlthcare

Cefazolin and Dextrose

B Braun

Cleocin Phosphate In Dextrose 5% In Plastic Container

Pharmacia and Upjohn

Halcion

Pharmacia and Upjohn

Hydralazine Hydrochloride

Cadila Pharms Ltd

Megace Es

Par Pharm

Ofloxacin

Cadila Pharms Ltd

Sancuso

Prostrakan Inc

Trulicity

Eli Lilly and Co

Vasostrict

Par Sterile Products

Zofran

Glaxosmithkline

Zofran

Glaxosmithkline

Zofran

Glaxosmithkline

Zofran Odt

Glaxosmithkline

Zofran Preservative Free

Glaxosmithkline

Zuplenz

Galena Biopharma Inc

September 17, 2014

Drug Name

Sponsor

Amoxapine

Watson Labs

Citalopram Hydrobromide

Roxane

Daliresp

Forest Res Inst Inc

Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Hospira

Docetaxel

Actavis Inc

Lactated Ringer's In Plastic Container

Hospira

Serostim

Emd Serono

Serostim Lq

Emd Serono

Sodium Chloride 0.45% In Plastic Container

Hospira

Sodium Chloride 0.9% In Plastic Container

Hospira

Stendra

Vivus

Tofranil

Mallinckrodt Inc

Venlafaxine Hydrochloride

Teva

Vivactil

Odyssey Pharms

September 16, 2014

Drug Name

Sponsor

Ambisome

Astellas

Complera

Gilead Sciences Inc

Fortical

Upsher Smith

Movantik

Astrazeneca Pharms

Tegretol

Novartis

Tegretol

Novartis

Tegretol

Novartis

Tegretol-Xr

Novartis

Tobramycin Sulfate

Akorn

Tobramycin Sulfate

Xellia Pharms Aps

Varithena

Provensis

September 15, 2014

Drug Name

Sponsor

Adenosine

Emcure Pharms Ltd

Aminosyn Ii 10% In Plastic Container

Hospira

Amoxicillin

Aurobindo Pharma Ltd

Budesonide

Salix Pharms

Centany

Perrigo New York

Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Container

Baxter Hlthcare

Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Container

Baxter Hlthcare

Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Container

Baxter Hlthcare

Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Container

Baxter Hlthcare

Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Container

Baxter Hlthcare

Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Container

Baxter Hlthcare

Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Container

Baxter Hlthcare

Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Container

Baxter Hlthcare

Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Container

Baxter Hlthcare

Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Container

Baxter Hlthcare

Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Container

Baxter Hlthcare

Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Container

Baxter Hlthcare

Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container

Baxter Hlthcare

Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container

Baxter Hlthcare

Clopidogrel

Sciegen Pharms Inc

Glipizide

Zydus Pharms Usa Inc

Membraneblue

Dorc

Methylin

Mallinckrodt

Methylin

Mallinckrodt

Setlakin

Novast Labs Ltd

Travasol 10% In Plastic Container

Baxter Hlthcare

Travasol 5.5% In Plastic Container

Baxter Hlthcare

Travasol 8.5% In Plastic Container

Baxter Hlthcare

September 12, 2014

Drug Name

Sponsor

Advil Liqui-Gels

Pfizer

Advil Migraine Liqui-Gels

Pfizer

Afinitor

Novartis

Allegra Allergy

Sanofi Aventis Us

Allegra Hives

Sanofi Aventis Us

Amlodipine and Valsartan

Torrent Pharms Ltd

An-Sulfur Colloid

Pharmalucence

Children's Allegra Allergy

Sanofi Aventis Us

Children's Allegra Hives

Sanofi Aventis Us

Clindamycin Phosphate and Benzoyl Peroxide

Mylan Pharms Inc

Daptomycin

Hospira Inc

Emtricitabine;Tenofovir Disoproxil Fumarate;Nevirapine

Mylan Labs Ltd

Forteo

Lilly

Glycine 1.5% In Plastic Container

B Braun

Humalog

Lilly

Humalog Kwikpen

Lilly

Humalog Mix 50/50

Lilly

Humalog Mix 50/50 Kwikpen

Lilly

Humalog Mix 50/50 Pen

Lilly

Humalog Mix 75/25

Lilly

Humalog Mix 75/25 Kwikpen

Lilly

Humalog Mix 75/25 Pen

Lilly

Humalog Pen

Lilly

Humatrope

Lilly

Humulin 70/30

Lilly

Humulin 70/30 Pen

Lilly

Humulin N

Lilly

Mycophenolate Mofetil

Roxane

Mycophenolate Mofetil

Roxane

Naprelan

Almatica Pharma Inc

Pomalyst

Celgene

Revlimid

Celgene

Thalomid

Celgene

Vibra-Tabs

Pfizer

Vibramycin

Pfizer

Vibramycin

Pfizer

Vibramycin

Pfizer

Zoloft

Pfizer

Zoloft

Pfizer


CDER Workshops, Meetings and Conferences

Upcoming

  • FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
  • FDA’s GDUFA Public Hearing on Policy Development, September 17, 2014
  • FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014; September 18-19, 2014, Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814. Meeting Information
  • 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 11, 2014

4cigarettes.net

September 05, 2014

az-smokes.com

September 05, 2014

www.ilovecigarette.com

September 05, 2014

www.mrsnuff.com

September 05, 2014

www.snuff.me.uk

September 04, 2014

John W Hollis Inc

September 03, 2014

Wabash Way Holsteins, LLC

September 02, 2014

Modern Macaroni Co Ltd

August 29, 2014

Glenville Farms

 

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

September 18, 2014

September 17, 2014

September 15, 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
Thursday - 21 CFR Part 866

Friday, September 19, 2014

NONE


Thursday, September 18, 2014

 

Rules and Regulations

 

Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System

 

Pages 56009 - 56011 [FR DOC # 2014-22254]

PDF | Text

 
 

Proposed Rules

 

Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System

 

Pages 56027 - 56029 [FR DOC # 2014-22255]

PDF | Text

 

Wednesday, September 17, 2014

 

Notices

 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles

 

Pages 55800 - 55800 [FR DOC # 2014-22123]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent

 

Pages 55800 - 55801 [FR DOC # 2014-22089]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug

 

Pages 55801 - 55804 [FR DOC # 2014-22088]

PDF | Text

 
 

Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

 

Pages 55804 - 55812 [FR DOC # 2014-22086]

PDF | Text

 
 

Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive Standards; Availability

 

Pages 55813 - 55813 [FR DOC # 2014-22068]

PDF | Text

 
 

Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Proper Justification of Impurity Limits; Availability

 

Pages 55813 - 55814 [FR DOC # 2014-22110]

PDF | Text

 
 

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

 

Pages 55814 - 55815 [FR DOC # 2014-22071]

PDF | Text

 
 

Electronic Cigarettes and the Public Health; Public Workshop

 

Pages 55815 - 55816 [FR DOC # 2014-22122]

PDF | Text

 

Tuesday, September 16, 2014

 

Notices

 

Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability; Correction

 

Pages 55497 - 55497 [FR DOC # 2014-22015]

PDF | Text

 

Monday, September 15, 2014

 

Proposed Rules

 

Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices

 

Pages 54927 - 54927 [FR DOC # 2014-21816]

PDF | Text

 
 

Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers

 

Pages 54927 - 54936 [FR DOC # 2014-21814]

PDF | Text

 
 

Notices

 

Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Withdrawal of Draft Guidance

 

Pages 54986 - 54987 [FR DOC # 2014-21815]

PDF | Text

 


 

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