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GXPNews.com - FDA News and Announcements August 4 - August 8, 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
> Warning Letters
> FDA News & Events
> Biologics Evaluation & Research (CBER)
> Center for Device & Radiology Heath (CDRH)
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Meetings, Notices, & Rule Changes

>FDA and EU Regulations
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email: JCuspilich@fda.com

Whats New with CDER

August 8, 2014

August 7, 2014

August 6, 2014

August 5, 2014

August 4, 2014

August 1, 2014


Drug Approvals

August 7, 2014

Drug Name

Sponsor

Angiomax

Medicines Co

Axert

Janssen Pharms

Delflex W/ Dextrose 1.5% In Plastic Container

Fresenius Medcl

Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container

Fresenius Medcl

Delflex W/ Dextrose 2.5% In Plastic Container

Fresenius Medcl

Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container

Fresenius Medcl

Delflex W/ Dextrose 4.25% In Plastic Container

Fresenius Medcl

Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container

Fresenius Medcl

Humira

Abbvie Inc

Humira

Abbvie Inc

Norpramin

Sanofi Aventis Us

Optimark

Mallinckrodt

Optimark

Mallinckrodt

Optimark In Plastic Container

Mallinckrodt

August 6, 2014

Drug Name

Sponsor

Fludeoxyglucose F18

Univ Iowa Hosps

Orbactiv

Medicines Co

Phentermine Hydrochloride

Aurolife Pharma Llc

August 5, 2014

Drug Name

Sponsor

Bimatoprost

Sandoz Inc

Loestrin Fe 1.5/30

Warner Chilcott Llc

Tenofovir Disoproxil Fumarate

Macleods Pharma

Vincristine Sulfate Pfs

Hospira

Zosyn

Wyeth Pharms Inc

August 4, 2014

Drug Name

Sponsor

Ketorolac Tromethamine

Agila Speclts

Myfortic

Novartis

Sirturo

Janssen Therap

August 3, 2014

Drug Name

Sponsor

Miralax

Schering Plough

August 1, 2014

Drug Name

Sponsor

Differin

Galderma Labs Lp

Epiduo

Galderma Labs Lp

Halaven

Eisai Inc

Inlyta

Pfizer

Jardiance

Boehringer Ingelheim

Keppra Xr

Ucb Inc

Loestrin Fe 1/20

Warner Chilcott

Lumizyme

Genzyme

Metronidazole In Plastic Container

Hospira

Oxycodone Hydrochloride

Lannett Holdings Inc

Sterile Water For Injection In Plastic Container

Hospira

Tyvaso

United Therap


CDER Workshops, Meetings and Conferences

Upcoming

  • Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments. September 5, 2014. 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
  • Regulation of Nonprescription Drug Products – Question and Answer Sessions. August 4-5, 2014. Meeting Information
  • Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials; Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER; Request for Comments.  August 11, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. 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
  • 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

July 25, 2014

Mezotrace Corporation

July 24, 2014

Wabash Cigar Store, Inc.

July 23, 2014

Casa di Pasta, Inc.

July 23, 2014

Julian Bakery, Inc.

July 22, 2014

H. A. R. Maspeth Corp.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 8, 2014

August 7, 2014

August 6, 2014

August 5, 2014

August 4, 2014

August 3, 2014

August 1, 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, August 8, 2014

NONE


Thursday, August 7, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption

 

Pages 46269 - 46270 [FR DOC # 2014-18640]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards

 

Pages 46270 - 46270 [FR DOC # 2014-18600]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations

 

Pages 46270 - 46272 [FR DOC # 2014-18665]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees

 

Pages 46272 - 46272 [FR DOC # 2014-18609]

PDF | Text

 
 

Center for Devices and Radiological Health: Experiential Learning Program; General Training Program

 

Pages 46272 - 46274 [FR DOC # 2014-18662]

PDF | Text

 

Wednesday, August 6, 2014

 

Notices

 

Draft Guidance for Industry on Upper Facial Lines: Developing Botulinum Toxin Drug Products; Availability

 

Pages 45812 - 45813 [FR DOC # 2014-18564]

PDF | Text

 
 

In Vitro Companion Diagnostic Devices; Guidance for Industry and FDA Staff; Availability

 

Pages 45813 - 45814 [FR DOC # 2014-18538]

PDF | Text

 
 

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 45814 - 45815 [FR DOC # 2014-18616]

PDF | Text

 

Tuesday, August 5, 2014

 

Notices

 

Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 45447 - 45448 [FR DOC # 2014-18470]

PDF | Text

 
 

Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability

 

Pages 45448 - 45450 [FR DOC # 2014-18169]

PDF | Text

 

Monday, August 4, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Commissioner's Fellowship Program

 

Pages 45196 - 45197 [FR DOC # 2014-18302]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations

 

Pages 45197 - 45198 [FR DOC # 2014-18322]

PDF | Text

 
 

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

 

Pages 45198 - 45199 [FR DOC # 2014-18304]

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