Sign up Today!
GXPNews.com - FDA News and Announcements August 11 - August 15, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
  The GMP International Master Reference Guide  
> Need information on conducting Clinical Trials?  Get the Master FDA Clinical Reference Guide Now
> Need information on Drug and Device Manufacturing?  Get the Master FDA GMP International Reference Guide Now

Pharmaceutical GMP GuidelinesMedical Device GuidelinesClinical GuidelinesLaboratory GuidelinesFood, Drug, and Cosmetic GuidelinesBiologics and Laboratory GuidelinesPart 11 and Computer SystemsEU, Japanese, Chinese, Spanish, ICH, and other Misc. Gudielines

> 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)
> Federal Register -
Meetings, Notices, & Rule Changes

>FDA and EU Regulations
Not sure what books to order?
email: JCuspilich@fda.com

Whats New with CDER

August 15, 2014

August 14, 2014

August 13, 2014

August 12, 2014

August 11, 2014

August 8, 2014


Drug Approvals

August 14, 2014

Drug Name

Sponsor

Avastin

Genentech

Colcrys

Takeda Pharms Usa

Combivent Respimat

Boehringer Ingelheim

Commit

Glaxosmithkline Cons

Decitabine

Sun Pharma Global

Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate

Macleods Pharms Ltd

Lotensin Hct

Us Pharms Holdings I

Metopirone

Hra Pharma

Metopirone

Hra Pharma

Migranal

Valeant

Pegintron

Schering

Pegintron

Schering

Pradaxa

Boehringer Ingelheim

Sustiva

Bristol Myers Squibb

Sustiva

Bristol Myers Squibb

Sylatron

Schering

Vascepa

Amarin Pharms

August 13, 2014

Drug Name

Sponsor

Belsomra

Merck and Co Inc

Depocyt

Pacira Pharms Inc

Diprolene

Merck Sharp Dohme

Diprolene

Merck Sharp Dohme

Diprolene Af

Merck Sharp Dohme

Etomidate

Emcure Pharms Ltd

Exparel

Pacira Pharms Inc

Forteo

Lilly

Mekinist

Glaxosmithkline Llc

Navelbine

Pierre Fabre

Neuraceq

Piramal Imaging

Nilandron

Covis Pharma Sarl

Prometrium

Abbvie Inc

Toviaz

Pfizer

Zyban

Glaxosmithkline

August 12, 2014

Drug Name

Sponsor

Bexarotene

Banner Pharmacaps

Byetta

Astrazeneca Ab

Coartem

Novartis

Eliquis

Bristol Myers Squibb

Emend

Merck

Emend

Merck and Co Inc

Estring

Pharmacia and Upjohn

Femtrace

Warner Chilcott Llc

Lastacaft

Allergan

Mobic

Boehringer Ingelheim

Nutrilipid 10%

B Braun

Nutrilipid 20%

B Braun

Rayos

Horizon Pharma

Ribavirin

Sandoz Inc

Rituxan

Genentech

Robaxin

Hikma Maple

Suboxone

Reckitt Benckiser

Tranexamic Acid

Emcure Pharms Ltd

Vimpat

Ucb Inc

Vimpat

Ucb Inc

Vimpat

Ucb Inc

August 11, 2014

Drug Name

Sponsor

Alimta

Lilly

Concerta

Janssen Pharms

Gemzar

Lilly

Glucagon

Lilly

Gonal-F

Emd Serono

Gonal-F

Emd Serono

Gonal-F Rff

Emd Serono

Humatrope

Lilly

Intron A

Schering

Namenda

Forest Labs

Pegintron

Schering

Pegintron

Schering

Quinidine Gluconate

Lilly

Saizen

Emd Serono

Serostim

Emd Serono

Serostim Lq

Emd Serono

Sylatron

Schering

Zorvolex

Iroko Pharms Llc

Zyprexa

Lilly

August 8, 2014

Drug Name

Sponsor

Capecitabine

Mylan Pharms Inc

Farxiga

Astrazeneca Ab

Invokamet

Janssen Pharms

Juxtapid

Aegerion

Silenor

Pernix Theraps Llc

Velcade

Millennium Pharms

Videx

Bristol Myers Squibb

Xanax

Pharmacia and Upjohn


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
  • 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

August 05, 2014

Garden of Flavor LLC

August 05, 2014

Goodlife Juices

August 04, 2014

Oberholtzer, Joseph N.

July 31, 2014

Dean and Jean Mikalunas

July 31, 2014

Faihopity Farms, LP

July 31, 2014

Iberia Foods Company of New York, Inc

July 31, 2014

Wang Globalnet

July 30, 2014

Taiyo Seafood NY Inc

July 29, 2014

Imer Barton

July 28, 2014

Connecticut Valley Tobacconist, LLC

July 28, 2014

Dwyer & Manning Inc

July 24, 2014

Healthtime dba Deer Garden Foods

 

Whats New with FDA


Whats New with CBER

 


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 15, 2014

August 14, 2014

August 13, 2014

August 12, 2014

August 11, 2014

August 8, 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
Tuesday - 21 CFR Part 172

Friday, August 15, 2014

 

Notices

 

Pilot Program for Qualification of Medical Device Development Tools

 

Pages 48170 - 48172 [FR DOC # 2014-19360]

PDF | Text

 

Thursday, August 14, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers

 

Pages 47642 - 47648 [FR DOC # 2014-19241]

PDF | Text

 
 

Determination That DRIXORAL (Dexbrompheniramine Maleate; Pseudoephedrine Sulfate) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 47648 - 47649 [FR DOC # 2014-19272]

PDF | Text

 
 

Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products; Availability

 

Pages 47649 - 47650 [FR DOC # 2014-19267]

PDF | Text

 
 

Revised Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format; Availability

 

Pages 47650 - 47651 [FR DOC # 2014-19264]

PDF | Text

 
 

De Novo Classification Process (Evaluation of Automatic Class III Designation); Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 47651 - 47653 [FR DOC # 2014-19253]

PDF | Text

 
 

Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs; Reopening of the Comment Period

 

Pages 47654 - 47654 [FR DOC # 2014-19261]

PDF | Text

 
 

Clinical Development of Drugs for the Prevention of Infections Caused by Staphylococcus aureus in the Health Care Setting; Public Workshop

 

Pages 47654 - 47655 [FR DOC # 2014-19257]

PDF | Text

 
 

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

 

Pages 47655 - 47655 [FR DOC # 2014-19255]

PDF | Text

 

Wednesday, August 13, 2014

NONE


Tuesday, August 12, 2014

 

Rules and Regulations

 

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3

 

Pages 46993 - 46996 [FR DOC # 2014-18969]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting

 

Pages 47145 - 47148 [FR DOC # 2014-19004]

PDF | Text

 

Monday, August 11, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

 

Pages 46836 - 46837 [FR DOC # 2014-18943]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing

 

Pages 46838 - 46839 [FR DOC # 2014-18945]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability

 

Pages 46839 - 46840 [FR DOC # 2014-18944]

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