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GXPNews.com - FDA News and Announcements September 29 - October 03, 2014
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> Center for Drug Evaluation & Research (CDER)
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Whats New with CDER

October 3, 2014

October 2, 2014

October 1, 2014

September 30, 2014

September 29, 2014

September 26, 2014


Drug Approvals

October 2, 2014

Drug Name

Sponsor

Adenosine

Akorn Inc

Hetlioz

Vanda Pharms Inc

Monoket

Kremers Urban Pharms

Nitro-Dur

Merck Sharp Dohme

Nitroglycerin In Dextrose 5%

Baxter Hlthcare

Pitocin

Par Sterile Products

October 1, 2014

Drug Name

Sponsor

Furosemide

Dava Pharms Inc

Mircera

Hoffman-La Roche

September 30, 2014

Drug Name

Sponsor

Amoxil

Dr Reddys Labs Inc

Ampyra

Acorda

Augmentin '125'

Dr Reddys Labs Inc

Augmentin '200'

Dr Reddys Labs Inc

Augmentin '250'

Dr Reddys Labs Inc

Augmentin '250'

Dr Reddys Labs Inc

Augmentin '400'

Dr Reddys Labs Inc

Augmentin '500'

Dr Reddys Labs Inc

Augmentin '875'

Dr Reddys Labs Inc

Augmentin Es-600

Dr Reddys Labs Inc

Augmentin Xr

Dr Reddys Labs Inc

Azactam

Bristol Myers Squibb

Bloxiverz

Eclat Pharms Llc

Brintellix

Takeda Pharms Usa

Cambia

Depomed Inc

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

Clozaril

Novartis

Dianeal 137 W/ Dextrose 1.5% In Plastic Container

Baxter Hlthcare

Dianeal 137 W/ Dextrose 2.5% In Plastic Container

Baxter Hlthcare

Dianeal 137 W/ Dextrose 4.25% In Plastic Container

Baxter Hlthcare

Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container

Baxter Hlthcare

Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container

Baxter Hlthcare

Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container

Baxter Hlthcare

Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container

Baxter Hlthcare

Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container

Baxter Hlthcare

Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container

Baxter Hlthcare

Differin

Galderma Labs Lp

Frova

Endo Pharms

Guanidine Hydrochloride

Merck Sharp Dohme

Humira

Abbvie Inc

Humira

Abbvie Inc

Humulin N

Lilly

Hyzaar

Merck Sharp Dohme

Invanz

Merck Sharp Dohme

K-Tab

Abbvie

Lactated Ringer's and Dextrose 5% In Plastic Container

Baxter Hlthcare

Lactated Ringer's In Plastic Container

Baxter Hlthcare

Lactated Ringer's In Plastic Container

Baxter Hlthcare

Lactated Ringer's In Plastic Container

Baxter Hlthcare

Lazanda

Depomed Inc

Mestinon

Valeant Pharm North

Northera

Lundbeck Na Ltd

Nulojix

Bristol Myers Squibb

Omega-3-Acid Ethyl Esters

Apotex Inc

Potassium Chloride

Abbvie

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

Prometrium

Abbvie Inc

Prometrium

Abbvie Inc

Pyridostigmine Bromide

Us Army

Raltegravir

Hetero Labs Ltd Iii

Remeron

Organon Usa Inc

Remeron Soltab

Organon Usa Inc

Ringer's In Plastic Container

Baxter Hlthcare

Ringer's In Plastic Container

Baxter Hlthcare

Saizen

Emd Serono

Serostim

Emd Serono

Serostim Lq

Emd Serono

Surmontil

Odyssey Pharms

Tasmar

Valeant Pharms Llc

Tobi Podhaler

Novartis

Ultresa

Forest Labs Inc

Vytorin

Msd Intl

Yasmin

Bayer Hlthcare

Yaz

Bayer Hlthcare

Zetia

Msd Intl Gmbh

Zyprexa

Lilly

September 29, 2014

Drug Name

Sponsor

Abilify Maintena Kit

Otsuka Pharm Co Ltd

Alinia

Romark

Clozaril

Novartis

Cortrosyn

Amphastar Pharms Inc

Cozaar

Merck Sharp Dohme

Dextrose 5% In Plastic Container

B Braun

Flo-Pred

Taro

Fludarabine Phosphate

Sandoz

Hyzaar

Merck Sharp Dohme

Lumigan

Allergan

Lumigan

Allergan

Nexterone

Baxter Hlthcare

Relistor

Salix Pharms

Relistor

Salix Pharms

Skelaxin

King Pharms

Sodium Chloride 0.9% In Sterile Plastic Container

Baxter Hlthcare

Versacloz

Jazz Pharms Iii

Voltaren

Novartis

Zingo

Powder Pharms

Zovirax

Valeant Bermuda

September 26, 2014

Drug Name

Sponsor

Acetic Acid 0.25% In Plastic Container

Baxter Hlthcare

Allopurinol

Watson Labs

Aminoacetic Acid 1.5% In Plastic Container

Baxter Hlthcare

Cubicin

Cubist

Dextrose 5% In Sodium Chloride 0.2% In Plastic Container

Baxter Hlthcare

Dextrose 5% In Sodium Chloride 0.33% In Plastic Container

Baxter Hlthcare

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

Baxter Hlthcare

Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Container

Baxter Hlthcare

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

Baxter Hlthcare

Diclofenac Sodium

Watson Labs

Diovan

Novartis

Elidel

Valeant Bermuda

Firmagon

Ferring

Hicon

Jubilant Draximage

Iluvien

Alimera Sciences Inc

Lactated Ringer's In Plastic Container

Baxter Hlthcare

Letairis

Gilead

Linezolid

Hospira Inc

Loestrin 21 1.5/30

Warner Chilcott Llc

Loestrin 21 1/20

Warner Chilcott Llc

Loestrin Fe 1/20

Warner Chilcott

Mekinist

Glaxosmithkline Llc

Mitigare

Hikma Pharms Llc

Namenda Xr

Forest Labs

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

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

Baxter Hlthcare

Protonix Iv

Wyeth Pharms Inc

Qsymia

Vivus

Qsymia

Vivus

Sodium Iodide I-131

Jubilant Draximage

Sterile Water For Injection In Plastic Container

Baxter Hlthcare

Sterile Water In Plastic Container

Baxter Hlthcare

Tagamet Hb

Medtech Prods

Xolair

Genentech

Zenpep

Forest Labs Inc

Zutripro

Cypress Pharm

Zyrtec Allergy

Mcneil Consumer

Zyrtec Hives Relief

Mcneil Consumer


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 24, 2014

Calcomp Nutrition Llc

September 23, 2014

cheapcigarettestoday.com

September 23, 2014

Double E Dairy LLC

September 23, 2014

www.smoko.biz

September 22, 2014

Losurdo Foods, Inc.

September 22, 2014

Petrie Farms

September 19, 2014

www.cheapcigarettesone.com

September 19, 2014

www.cigarettecart.com

September 18, 2014

ArjoHuntleigh Inc.

September 18, 2014

Middle East Bakery, Inc.

September 17, 2014

Express Diagnostics Int'l., Inc.

September 17, 2014

Poinciana Milling Complex

September 17, 2014

Well Luck Co. Inc.

September 17, 2014

www.cigarettes-online-store.com

September 16, 2014

Jerry Slabaugh

September 16, 2014

www.abroadcigarettes.com

Whats New with FDA

October 2014

September 2014


Whats New with CBER


CBER Workshops, Meetings and Conferences

FDA Industry Meeting: Electronic Postmarket Safety Reporting Updates
October 27, 2014; FDA White Oak Campus - Silver Spring, MD


Whats New with CDRH

October 3, 2014

October 2, 2014

October 1, 2014

September 30, 2014

September 29, 2014

September 26, 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, October 3, 2014

 

Proposed Rules

 

Casa de Mesquite LLC; Filing of Food Additive Petition

 

Pages 59699 - 59699 [FR DOC # 2014-23597]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures

 

Pages 59775 - 59776 [FR DOC # 2014-23551]

PDF | Text

 
 

Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Availability

 

Pages 59776 - 59779 [FR DOC # 2014-23596]

PDF | Text

 
 

Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Availability

 

Pages 59779 - 59782 [FR DOC # 2014-23586]

PDF | Text

 
 

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

 

Pages 59782 - 59783 [FR DOC # 2014-23548]

PDF | Text

 
 

Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

 

Pages 59783 - 59783 [FR DOC # 2014-23549]

PDF | Text

 

Thursday, October 2, 2014

 

Notices

 

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 59493 - 59494 [FR DOC # 2014-23457]

PDF | Text

 

Wednesday, October 1, 2014

 

Notices

 

Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2015

 

Pages 59275 - 59276 [FR DOC # 2014-23320]

PDF | Text

 

Tuesday, September 30, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration

 

Pages 58786 - 58786 [FR DOC # 2014-23236]

PDF | Text

 

Monday, September 29, 2014

 

Proposed Rules

 

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

 

Pages 58433 - 58473 [FR DOC # 2014-22447]

PDF | Text

 
 

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

 

Pages 58573 - 58599 [FR DOC # 2014-22448]

PDF | Text

 
 

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

 

Pages 58475 - 58521 [FR DOC # 2014-22445]

PDF | Text

 
 

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

 

Pages 58523 - 58572 [FR DOC # 2014-22446]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports

 

Pages 58355 - 58357 [FR DOC # 2014-23059]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Cosmetic Registration Program

 

Pages 58357 - 58357 [FR DOC # 2014-23066]

PDF | Text

 
 

Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Draft Guidance for Industry; Reopening of the Comment Period

 

Pages 58357 - 58358 [FR DOC # 2014-23063]

PDF | Text

 
 

Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007; Availability

 

Pages 58358 - 58358 [FR DOC # 2014-23058]

PDF | Text

 
 

Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Draft Guidance for Industry; Reopening of the Comment Period

 

Pages 58359 - 58359 [FR DOC # 2014-23064]

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