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GXPNews.com - FDA News and Announcements October 27 - October 31, 2014
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Master FDA GMP International Reference Guide

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

> Job Board - Post your Job

>FDA and EU Regulations
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Call 856-810-7331 and Ask for John Cuspilich, QA/RA

Whats New with CDER

October 31, 2014

October 30, 2014

October 29, 2014

October 28, 2014

October 27, 2014

October 24, 2014


Drug Approvals

October 30, 2014

Drug Name

Sponsor

Ammonia N 13

The Brigham and Women's Hospital Inc

Bystolic

Forest Labs

Celecoxib

Lupin Ltd

Diflucan

Pfizer

Diflucan

Pfizer

Docefrez

Sun Pharma Global

Envarsus Xr

Veloxis Pharma Inc

Fludeoxyglucose F18

The Brigham and Women's Hospital Inc

Fludeoxyglucose F18

Hot Shots Nm Llc

Humulin R

Lilly

Humulin R Pen

Lilly

Imatinib Mesylate

Apotex Inc

Lamotrigine

Par Pharm Inc

Locoid

Precision Dermat

Locoid

Precision Dermat

Locoid

Precision Dermat

Locoid

Precision Dermat

Lopressor

Us Pharms Holdings I

Montelukast Sodium

Unimark Remedies Ltd

Montelukast Sodium

Unimark Remedies Ltd

Mycophenolic Acid

Teva Pharms Usa

Nascobal

Par Pharm

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

Famy Care Ltd

Nutrestore

Emmaus Medcl

Omtryg

Trygg

Orfadin

Swedish Orphan

Symbyax

Lilly

Vyvanse

Shire Development

Zavesca

Actelion Pharms Ltd

Zykadia

Novartis Pharms Corp

October 29, 2014

Drug Name

Sponsor

Bio-Tropin

Ferring

Dymista

Meda Pharms

Edluar

Meda Pharms

Fludeoxyglucose F18

Trustees Of The U Of Penn

Fludeoxyglucose F18

Childrens Hospital Of Mi

Fludeoxyglucose F18

Centre For Probe Dev and Commercialization

Humira

Abbvie Inc

Humira

Abbvie Inc

Letairis

Gilead

Naropin

Fresenius Kabi Usa

Piperacillin and Tazobactam

Sandoz Inc

Singulair

Merck

Sodium Fluoride F18

Essential Isotopes Llc

Tev-Tropin

Ferring

Xigduo Xr

Astrazeneca Ab

October 28, 2014

Drug Name

Sponsor

Adapalene

Actavis Mid Atlantic

Carisoprodol

Natco Pharma Ltd

Darunavir Ethanolate

Hetero Labs Unit Iii

Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride

Tris Pharma Inc

Idkit:hp

Exalenz Bioscience

Maraviroc

Hetero Labs Unit Iii

Metoprolol Tartrate

Rubicon Research Pvt Ltd

Nicardipine Hydrochloride

Exela Pharma Science

Quetiapine Fumarate

Alembic Pharms Ltd

Sirolimus

Dr Reddys Labs Ltd

Somatuline Depot

Ipsen Pharma

Soriatane

Stiefel Labs Inc

Vibramycin

Pfizer

October 27, 2014

Drug Name

Sponsor

Ammonia N 13

Global Isotopes Llc

Azelastine Hydrochloride

Roxane

Bystolic

Forest Labs

Carisoprodol

Orient Pharma Co Ltd

Delzicol

Warner Chilcott Llc

Dtpa

Draximage

Fludeoxyglucose F-18

Global Isotopes Llc

Fluocinonide

Taro

Ivermectin

Edenbridge Pharma Llc

Lyrica

Novel Labs Inc

Methylphenidate Hydrochloride

Barr Labs Inc

Nasonex

Merck Sharp Dohme

Nevirapine

Mylan Pharms Inc

Orfadin

Swedish Orphan

Oxymorphone Hydrochloride

Par Pharm Inc

Ritalin La

Novartis

Sodium Fluoride F-18

Global Isotopes Llc

Trandate

Prometheus Labs

Ultram Er

Valeant Intl

Zyflo Cr

Chiesi Usa Inc

October 25, 2014

Drug Name

Sponsor

Cyclophosphamide

Baxter Hlthcare

October 24, 2014

Drug Name

Sponsor

Dilatrate-Sr

Auxilium Pharms Llc


CDER Workshops, Meetings and Conferences

Upcoming

  • Clinical Investigator Training Course, November 4-6, 2014, The Holiday Inn Washington, 10000 Baltimore Avenue, College Park, MD. Meeting information
  • FDA Outreach to the Pediatric Cancer Advocacy Community, November 18, 2014, FDA White Oak Campus, Bldg. 31 The Great Room A, Silver Spring, MD. Meeting information

This Weeks Warning Letters:

Letter Issue Date

Company Name

October 21, 2014

DNG Trading & Milling, LLC

October 16, 2014

Vitalab Co Inc

October 15, 2014

Citrus Fit

October 15, 2014

Health & Herbs

October 10, 2014

IL Pastaio, Inc.

October 10, 2014

Mills Dairy Farm LLC

October 10, 2014

Western/Scott Fetzer Company

October 09, 2014

Bethel Nutritional Consulting, Inc

October 09, 2014

Minerva Dairy Inc

October 09, 2014

Rex L. Jessee

October 08, 2014

Prospect Enterprises, Inc.

October 07, 2014

YoungYou International Inc

September 30, 2014

Stoney Hill Farms

September 26, 2014

http://www.buydiscountcigars.com

September 24, 2014

Beacon Hill Medical Pharmacy, P.C.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences

NONE


Whats New with CDRH

October 31, 2014

October 30, 2014

October 29, 2014

October 28, 2014

October 27, 2014

October 24, 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 -
Wednesday - 21 CFR Parts 510, 520, 522, 524, and 556

Friday, October 31, 2014

NONE


Thursday, October 30, 2014

 

Notices

 

Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations; Request for Comments

 

Pages 64603 - 64604 [FR DOC # 2014-25800]

PDF | Text

 
 

Request for Nominations on the Tobacco Products Scientific Advisory Committee

 

Pages 64605 - 64606 [FR DOC # 2014-25795]

PDF | Text

 

Wednesday, October 29, 2014

 

Notices

 

Agency Information Collection Activities: Proposed Collection; Comment Request-Generic Clearance To Conduct Pre-Testing of Surveys

 

Pages 64360 - 64360 [FR DOC # 2014-25723]

PDF | Text

 

Tuesday, October 28, 2014

 

Rules and Regulations

 

New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor

 

Pages 64114 - 64117 [FR DOC # 2014-25588]

PDF | Text

 
 

Notices

 

Determination That DIAMOX (Acetazolamide) Intravenous, 500 Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 64201 - 64202 [FR DOC # 2014-25534]

PDF | Text

 

Monday, October 27, 2014

 

Notices

 

Draft Guidance for Industry on Qualification for the Use of Galactomannan in Serum and Bronchoalveolar Lavage Fluid; Availability

 

Pages 63921 - 63922 [FR DOC # 2014-25532]

PDF | Text

 

Job Board

Post Jobs

  • 510(k) Submission Assistance - IVD Electronic Submission Subject Matter Experts - Assisting with the writing, and submission process for the US FDA CDRH Submission. US East Coast.
    Email resumes to info@auditing.com

 


























 

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