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GXPNews.com - FDA News and Announcements September 8 - September 12, 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
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Meetings, Notices, & Rule Changes

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Whats New with CDER

September 12, 2014

September 11, 2014

September 10, 2014

September 9, 2014

September 8, 2014

September 5, 2014


Drug Approvals

September 11, 2014

Drug Name

Sponsor

Argatroban In Sodium Chloride

Sandoz

Dorzolamide Hydrochloride

Watson Labs Inc

Hectorol

Genzyme Corp

Levalbuterol Hydrochloride

Teva Parenteral

Micronor

Janssen Pharms

Modicon 28

Janssen Pharms

Montelukast Sodium

Macleods Pharms Ltd

Opcicon One-Step

Sun Pharm Inds

Ortho-Novum 1/35-28

Janssen Pharms

Ortho-Novum 7/7/7-21

Janssen Pharms

Ortho-Novum 7/7/7-28

Janssen Pharms

September 10, 2014

Drug Name

Sponsor

Contrave

Orexigen Therapeutics Inc

Emsam

Somerset

Emsam

Somerset

Emsam

Somerset

Famciclovir

Hetero Labs Ltd V

Montelukast Sodium

Hetero Drugs Ltd

Mucinex

Reckitt Benckiser

Oxycodone Hydrochloride

Lannett Holdings Inc

Oxytocin

Fresenius Kabi Usa

Pantoprazole Sodium

Hetero Labs Ltd V

Xtandi

Astellas

September 9, 2014

Drug Name

Sponsor

Argatroban In Sodium Chloride

Eagle Pharms

Iclusig

Ariad

Levocetirizine Dihydrochloride

Sciegen Pharms Inc

Namenda Xr

Forest Labs

Tacrolimus

Fougera Pharms Inc

Ultratag

Mallinckrodt

Unithroid

Stevens J

September 8, 2014

Drug Name

Sponsor

Boniva

Roche

Brintellix

Takeda Pharms Usa

Buprenorphine and Naloxone

Teva Pharms Usa

Dextrose 10% In Plastic Container

Hospira

Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

Hospira

Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Kalbitor

Dyax Corp.

Lactated Ringer's In Plastic Container

Hospira

Nitrofurantoin

Novel Labs Inc

Normosol-M and Dextrose 5% In Plastic Container

Hospira

Ondansetron Hydrochloride

Qilu Pharma Co Ltd

Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

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

Hospira

Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

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

Hospira

Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

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

Hospira

Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 20meq In Dextrose 5% In Plastic Container

Hospira

Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

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

Hospira

Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 30meq In Dextrose 5% In Plastic Container

Hospira

Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

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

Hospira

Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 40meq In Dextrose 5% In Plastic Container

Hospira

Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container

Hospira

Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

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

Hospira

Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

Hospira

Ringer's In Plastic Container

Hospira

Sodium Chloride 0.45% In Plastic Container

Hospira

Sodium Chloride 0.45% In Plastic Container

B Braun

Sodium Chloride 0.9% In Plastic Container

Hospira

Sodium Chloride 0.9% In Plastic Container

B Braun

Sodium Chloride 3% In Plastic Container

B Braun

Sodium Chloride 5% In Plastic Container

B Braun

Velcade

Millennium Pharms

September 6, 2014

Drug Name

Sponsor

Solu-Cortef

Pharmacia and Upjohn

September 5, 2014

Drug Name

Sponsor

Besivance

Bausch and Lomb

Campath

Ilex Pharmaceuticals

Cerezyme

Genzyme

Ferric Citrate

Keryx Biopharma Inc

Lantus

Sanofi Aventis Us

Lantus Solostar

Sanofi Aventis Us

Mirvaso

Galderma Labs Lp

Mucinex Dm

Reckitt Benckiser

Olysio

Janssen Prods

Pegasys

Hoffman-La Roche

Pegasys

Hoffman-La Roche


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 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 02, 2014

Modern Macaroni Co Ltd

August 29, 2014

Japanese Specialty Food Distributors Ltd, Co.

August 28, 2014

CreAgri, Inc.

August 26, 2014

Microtest Laboratories, Inc.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

September 12, 2014

September 10, 2014

September 9, 2014

September 8, 2014

September 5, 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
Monday - 21 CFR Parts 520, 522, and 558, 21 CFR Parts 310, 314, 329, and 600
Wednesday - 21 CFR Part 866

Friday, September 12, 2014

 

Notices

 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Advertisements

 

Pages 54727 - 54727 [FR DOC # 2014-21727]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Health Care Practitioners for Device Labeling Format and Content

 

Pages 54727 - 54728 [FR DOC # 2014-21725]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

 

Pages 54728 - 54728 [FR DOC # 2014-21726]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Allegations of Regulatory Misconduct Associated With Medical Devices

 

Pages 54729 - 54729 [FR DOC # 2014-21769]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing

 

Pages 54729 - 54729 [FR DOC # 2014-21728]

PDF | Text

 
 

MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products

 

Pages 54729 - 54730 [FR DOC # 2014-21729]

PDF | Text

 
 

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice

 

Pages 54730 - 54730 [FR DOC # 2014-21780]

PDF | Text

 

Thursday, September 11, 2014

NONE


Wednesday, September 10, 2014

 

Rules and Regulations

 

Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents

 

Pages 53608 - 53609 [FR DOC # 2014-21479]

PDF | Text

 
 

Proposed Rules

 

Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction

 

Pages 53670 - 53670 [FR DOC # 2014-21481]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Testing Communications on Biological Products

 

Pages 53710 - 53711 [FR DOC # 2014-21533]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey

 

Pages 53711 - 53712 [FR DOC # 2014-21532]

PDF | Text

 
 

Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry; Availability

 

Pages 53712 - 53713 [FR DOC # 2014-21480]

PDF | Text

 

Tuesday, September 9, 2014

 

Notices

 

Exploring the Expansion of Conditional Approval to Appropriate Categories of New Animal Drugs

 

Pages 53430 - 53431 [FR DOC # 2014-21227]

PDF | Text

 
 

Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds

 

Pages 53431 - 53432 [FR DOC # 2014-21226]

PDF | Text

 
 

Advisory Committee Renewals; Correction

 

Pages 53430 - 53430 [FR DOC # 2014-21369]

PDF | Text

 

Monday, September 8, 2014

 

Rules and Regulations

 

New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin

 

Pages 53134 - 53138 [FR DOC # 2014-20325]

PDF | Text

 
 

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction

 

Pages 53133 - 53134 [FR DOC # 2014-21266]

PDF | Text

 
 

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections

 

Pages 53134 - 53134 [FR DOC # 2014-21267]

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