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GXPNews.com - FDA News and Announcements September 1 - September 5, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
   
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Whats New with CDER

September 5, 2014

September 4, 2014

September 3, 2014

September 02, 2014

August 29, 2014


Drug Approvals

September 3, 2014

Drug Name

Sponsor

Arthrotec

Gd Searle Llc

Dextrose 25%

Hospira

Dextrose 50% In Plastic Container

Hospira

Digoxin

Mylan Pharms Inc

Dorzolamide Hydrochloride and Timolol Maleate

Watson Labs Inc

Gatifloxacin

Hi-Tech Pharmacal

Milrinone Lactate

Hospira Inc

September 2, 2014

Drug Name

Sponsor

Ibandronate Sodium

Sagent Pharms

Ibandronate Sodium

Agila Speclts

Ibandronate Sodium

Emcure Pharms Ltd

Lactated Ringer's In Plastic Container

B Braun

Sodium Acetate In Plastic Container

Hospira

August 30, 2014

Drug Name

Sponsor

Avastin

Genentech

Vectibix

Amgen

Vimpat

Ucb Inc

Vimpat

Ucb Inc

Vimpat

Ucb Inc

 August 29, 2014

Drug Name

Sponsor

Citanest Forte Dental

Dentsply Pharm

Cleocin

Pharmacia and Upjohn

Cleocin T

Pharmacia and Upjohn

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

Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Dostinex

Pharmacia and Upjohn

Fentora

Cephalon

Hexalen

Eisai Inc

Omnitrope

Sandoz

Prosol 20% Sulfite Free In Plastic Container

Baxter Hlthcare

Riomet

Ranbaxy

Sterile Water For Injection In Plastic Container

B Braun

Vivitrol

Alkermes

Zanaflex

Acorda


CDER Workshops, Meetings and Conferences

Upcoming

  • PDA/FDA Joint Regulatory Conference and TRI Courses-Connecting Regulatory, Quality, Science & Compliance: Assuring Customer-Focused Outcomes Throughout the Product Lifecycle; September 8-10, 2014, Renaissance Hotel, Washington, D.C.  Meeting Information
  • Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting; September 5, 2014, The DoubleTree by Hilton Hotel, 8727 Colesville Road, Silver Spring, MD 20910. Meeting Information
  • Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information
  • 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
  •  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

August 26, 2014

Ipsi Specialty Foods

August 26, 2014

M & B Sea Products Inc

August 25, 2014

Ashland Farm, LLC

August 25, 2014

Seaview Fisheries Inc. dba Seaview Lobster Co.

August 25, 2014

www.cigarettesbox.com

August 25, 2014

www.cigoutlet.biz

August 22, 2014

Hoover Family Farm

August 21, 2014

cigarettstore.com

August 21, 2014

G. Wolf Enterprises, Inc.

August 21, 2014

www.discount-tobacco.com

 

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

September 5, 2014

September 4, 2014

September 3, 2014

September 2, 2014

August 27, 2014


CDRH Workshops, Meetings and Conferences



Weekly Rule Changes
Wednesday - 21 CFR Part 864

Friday, September 5, 2014

NONE


Thursday, September 4, 2014

 

Notices

 

Submission of a Proposed Draft Guidance for Industry on Developing Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of a Public Docket

 

Pages 52732 - 52733 [FR DOC # 2014-21051]

PDF | Text

 

Wednesday, September 3, 2014

 

Rules and Regulations

 

Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization

 

Pages 52195 - 52197 [FR DOC # 2014-20882]

PDF | Text

 

Tuesday, September 2, 2014

 

Proposed Rules

 

Richard C. Theuer; Withdrawal of Food Additive Petition and Citizen Petition

 

Pages 51922 - 51922 [FR DOC # 2014-20665]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act

 

Pages 52012 - 52016 [FR DOC # 2014-20719]

PDF | Text

 

Monday, September 1, 2014

NONE



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

 

 

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