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GXPNews.com - FDA News and Announcements September 22 - September 26, 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)
> Drug Approvals
> Meetings and Conferences
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Whats New with CDER

September 26, 2014

September 25, 2014

September 24, 2014

September 23, 2014

September 22, 2014

September 19, 2014


Drug Approvals

September 26, 2014

Drug Name

Sponsor

Acetic Acid 0.25% In Plastic Container

Baxter Hlthcare

Allopurinol

Watson Labs

Aminoacetic Acid 1.5% In Plastic Container

Baxter Hlthcare

Cubicin

Cubist

Dextrose 5% In Sodium Chloride 0.2% In Plastic Container

Baxter Hlthcare

Dextrose 5% In Sodium Chloride 0.33% In Plastic Container

Baxter Hlthcare

Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 15meq In Plastic Container

Baxter Hlthcare

Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Container

Baxter Hlthcare

Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 5meq In Plastic Container

Baxter Hlthcare

Diclofenac Sodium

Watson Labs

Diovan

Novartis

Elidel

Valeant Bermuda

Firmagon

Ferring

Hicon

Jubilant Draximage

Iluvien

Alimera Sciences Inc

Lactated Ringer's In Plastic Container

Baxter Hlthcare

Letairis

Gilead

Linezolid

Hospira Inc

Loestrin 21 1.5/30

Warner Chilcott Llc

Loestrin 21 1/20

Warner Chilcott Llc

Loestrin Fe 1/20

Warner Chilcott

Mekinist

Glaxosmithkline Llc

Mitigare

Hikma Pharms Llc

Namenda Xr

Forest Labs

Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Protonix Iv

Wyeth Pharms Inc

Qsymia

Vivus

Qsymia

Vivus

Sodium Iodide I-131

Jubilant Draximage

Sterile Water For Injection In Plastic Container

Baxter Hlthcare

Sterile Water In Plastic Container

Baxter Hlthcare

Tagamet Hb

Medtech Prods

Xolair

Genentech

Zenpep

Forest Labs Inc

Zutripro

Cypress Pharm

Zyrtec Allergy

Mcneil Consumer

Zyrtec Hives Relief

Mcneil Consumer

September 25, 2014

Drug Name

Sponsor

Abacavir Sulfate; Lamivudine

Hetero Labs Ltd V

Betoptic

Alcon

Brovana

Sunovion

Dextrose 5% and Potassium Chloride 0.075% In Plastic Container

Baxter Hlthcare

Dextrose 5% and Potassium Chloride 0.15% In Plastic Container

Baxter Hlthcare

Dextrose 5% and Potassium Chloride 0.224% In Plastic Container

Baxter Hlthcare

Dextrose 5% and Potassium Chloride 0.3% In Plastic Container

Baxter Hlthcare

Fludeoxyglucose F 18

Massachusetts General Hosp

Genotropin

Pharmacia and Upjohn

Genotropin Preservative Free

Pharmacia and Upjohn

Minocycline Hydrochloride

Ranbaxy Labs Ltd

Mitosol

Mobius Therap

Norditropin

Novo Nordisk Inc

Norditropin Flexpro

Novo Nordisk Inc

Norditropin Nordiflex

Novo Nordisk Inc

Click Here to View

Ken Lifescience

Click Here to View

Ken Lifescience

Premarin

Wyeth Pharms Inc

Qoliana

Alcon Pharms Ltd

Tasigna

Novartis

Timolol Maleate

Falcon Pharms

Uceris

Santarus Inc

Zinacef

Covis Injectables

Zinacef

Covis Injectables

Zinacef In Plastic Container

Covis Injectables

September 24, 2014

Drug Name

Sponsor

Armodafinil

Teva Pharms Usa Inc

Benzonatate

Thepharmanetwork Llc

Diovan

Novartis

Diovan Hct

Novartis

Exforge

Novartis

Exforge Hct

Novartis

Fortaz

Covis Injectables

Fortaz In Plastic Container

Covis Injectables

Fosrenol

Shire Llc

Fosrenol

Shire Development

Naftin

Merz Pharms

Raloxifene Hydrochloride

Invagen Pharms

Spiriva Respimat

Boehringer Ingelheim

Sterile Water In Plastic Container

Hospira

Tybost

Gilead Sciences Inc

Velphoro

Vifor Fresenius

Vibramycin

Pfizer

Vitekta

Gilead Sciences Inc

Xylocaine Viscous

Fresenius Kabi Usa

September 23, 2014

Drug Name

Sponsor

Azor

Daiichi Sankyo

Benicar

Daiichi Sankyo

Benicar Hct

Daiichi Sankyo

Humira

Abbvie Inc

Humira

Abbvie Inc

Humulin R

Lilly

Humulin R Pen

Lilly

Methylphenidate Hydrochloride

Vintage Pharms

Minivelle

Noven

Opana Er

Endo Pharms

Otezla

Celgene Corp

Ropivacaine Hydrochloride

Hospira Inc

Ropivacaine Hydrochloride

Sagent Pharms

Topotecan Hydrochloride

Teva Pharms Usa

Tribenzor

Daiichi Sankyo

Zanosar

Teva Pharms Usa

Zelboraf

Hoffmann La Roche

September 22, 2014

Drug Name

Sponsor

Benzaclin

Valeant Bermuda

Bloxiverz

Eclat Pharms Llc

Brevital Sodium

Par Sterile Products

Clindesse

Lumara Health Inc

Dorzolamide Hydrochloride and Timolol Maleate

Akorn Inc

Fuzeon

Roche

Methadone Hydrochloride

Mallinckrodt

Methadose

Mallinckrodt

Renova

Valeant Intl

Seasonique

Teva Branded Pharm

Sodium Fluoride F-18

Shertech Labs Llc

Zohydro Er

Zogenix Inc

September 20, 2014

Drug Name

Sponsor

Ceftin 

Glaxosmithkline

Ceftin

Glaxosmithkline


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

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


Whats New with CDRH

September 26, 2014

September 25, 2014

September 24, 2014

September 23, 2014

September 22, 2014

September 18, 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, September 26, 2014

 

Notices

 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions

 

Pages 57935 - 57935 [FR DOC # 2014-22981]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies

 

Pages 57935 - 57936 [FR DOC # 2014-22986]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle

 

Pages 57937 - 57939 [FR DOC # 2014-22982]

PDF | Text

 
 

Submissions for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 57939 - 57940 [FR DOC # 2014-22973]

PDF | Text

 
 

Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period

 

Pages 57940 - 57940 [FR DOC # 2014-22951]

PDF | Text

 
 

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

 

Pages 57940 - 57941 [FR DOC # 2014-22987]

PDF | Text

 
 

Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 57941 - 57942 [FR DOC # 2014-22905]

PDF | Text

 
 

Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction

 

Pages 57942 - 57944 [FR DOC # 2014-22983]

PDF | Text

 

Thursday, September 25, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive

 

Pages 57558 - 57559 [FR DOC # 2014-22808]

PDF | Text

 
 

Policy Clarification for Fluoroscopic Equipment Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 57559 - 57560 [FR DOC # 2014-22806]

PDF | Text

 
 

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

 

Pages 57560 - 57561 [FR DOC # 2014-22807]

PDF | Text

 

Wednesday, September 24, 2014

 

Notices

 

Announcement of Requirements and Registration for the 2014 Food and Drug Administration Food Safety Challenge

 

Pages 57110 - 57112 [FR DOC # 2014-22682]

PDF | Text

 
 

Custom Device Exemption; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 57112 - 57113 [FR DOC # 2014-22683]

PDF | Text

 
 

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL52); Draft Guidance for Industry on Bioequivalence: Blood Level Bioequivalence Study; Availability

 

Pages 57113 - 57114 [FR DOC # 2014-22681]

PDF | Text

 

Tuesday, September 23, 2014

 

Notices

 

Report on the Standardization of Risk Evaluation and Mitigation Strategies; Availability

 

Pages 56816 - 56818 [FR DOC # 2014-22513]

PDF | Text

 
 

Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting

 

Pages 56810 - 56814 [FR DOC # 2014-22514]

PDF | Text

 
 

Collaborative Approaches for Medical Device and Healthcare Cybersecurity; Public Workshop; Request for Comments

 

Pages 56814 - 56816 [FR DOC # 2014-22515]

PDF | Text

 

Monday, September 22, 2014

 

Proposed Rules

 

Reclassification of Iontophoresis Devices Intended for Any Other Purposes

 

Pages 56532 - 56538 [FR DOC # 2014-22453]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

 

Pages 56587 - 56588 [FR DOC # 2014-22461]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

 

Pages 56588 - 56588 [FR DOC # 2014-22452]

PDF | Text

 
 

Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft Guidance for Industry; Availability

 

Pages 56588 - 56589 [FR DOC # 2014-22450]

PDF | Text

 
 

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 56589 - 56590 [FR DOC # 2014-22444]

PDF | Text

 
 

First Annual Neonatal Scientific Workshop-Roadmap for Applying Regulatory Science to Neonates; Notice of Public Workshop

 

Pages 56590 - 56591 [FR DOC # 2014-22460]

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