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GXPNews.com - FDA News and Announcements June 09 - June 13, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
   

> Center for Drug Evaluation & Research (CDER)
> Drug Approvals
> Meetings and Conferences
> Biologics Evaluation & Research (CBER)
> Center for Device & Radiology Heath (CDRH)
> Federal Register -
Meetings, Notices, & Rule Changes

>FDA and EU Regulations

Whats New with CDER

June 13, 2004

June 12, 2014

June 11, 2014

June 10, 2014

June 9, 2014

June 6, 2014


Drug Approvals

June 12, 2014

Drug Name

Sponsor

Acetic Acid 0.25% In Plastic Container

Hospira

Bacteriostatic Sodium Chloride 0.9% In Plastic Container

Hospira

Bacteriostatic Water For Injection In Plastic Container

Hospira

Caverject

Pharmacia and Upjohn

Cerebyx

Parke Davis

Chromic Chloride In Plastic Container

Hospira

Cupric Chloride In Plastic Container

Hospira

Dovonex

Leo Pharma As

Ella

Lab Hra Pharma

Heparin Sodium

Shenzhen Techdow Pharma

Heparin Sodium

Shenzhen Techdow Pharma

Heparin Sodium

Shenzhen Techdow Pharma

Heparin Sodium

Shenzhen Techdow Pharma

Lamotrigine

Alembic Pharms Ltd

Manganese Chloride In Plastic Container

Hospira

Physiosol In Plastic Container

Hospira

Potassium Acetate In Plastic Container

Hospira

Ringer's In Plastic Container

Hospira

Sodium Acetate In Plastic Container

Hospira

Sodium Chloride 0.9% In Plastic Container

Hospira

Sodium Chloride 0.9% In Plastic Container

Hospira

Sodium Chloride In Plastic Container

Hospira

Sodium Lactate In Plastic Container

Hospira

Sodium Phosphates In Plastic Container

Hospira

Sterile Water For Injection In Plastic Container

Hospira

Taclonex

Leo Pharma As

Timentin

Glaxosmithkline

Timentin In Plastic Container

Glaxosmithkline

Tpn Electrolytes In Plastic Container

Hospira

Zebeta

Teva Womens

Ziac

Teva Womens

Zinc Chloride In Plastic Container

Hospira

June 11, 2014

Drug Name

Sponsor

Adempas

Bayer Hlthcare

Caverject Impulse

Pharmacia and Upjohn

Colgate Total

Colgate Palmolive

Doxazosin

Accord Hlthcare Inc

Duloxetine

Apotex Inc

Duloxetine Hydrochloride

Breckenridge Pharm

Erlotinib Hydrochloride

Mylan Pharma

Gadavist

Bayer Hlthcare

Magnevist

Bayer Hlthcare

Magnevist

Bayer Hlthcare

Nicorette

Glaxosmithkline

Nicorette

Glaxosmithkline

Nicorette (Mint)

Glaxosmithkline

Nicorette (Mint)

Glaxosmithkline

Noxafil

Merck Sharp Dohme

Prandimet

Novo Nordisk Inc

Sutent

Cppi Cv

June 10, 2014

Drug Name

Sponsor

Cleocin Phosphate

Pharmacia and Upjohn

Ddavp

Sanofi Aventis Us

Eszopiclone

Orchid Hlthcare

Foscavir

Clinigen Hlthcare

Gemzar

Lilly

Humulin N

Lilly

Lamictal

Glaxosmithkline Llc

Lamictal Cd

Glaxosmithkline Llc

Lamictal Odt

Glaxosmithkline Llc

Lamictal Xr

Glaxosmithkline Llc

Levemir

Novo Nordisk Inc

Levemir Flexpen

Novo Nordisk Inc

Levemir Flextouch

Novo Nordisk Inc

Levemir Innolet

Novo Nordisk Inc

Levemir Penfill

Novo Nordisk Inc

Risedronate Sodium

Apotex Inc

Risedronate Sodium

Sun Pharma Global

Risedronate Sodium

Sun Pharma Global

Risedronate Sodium

Mylan Pharms Inc

Trobicin

Pfizer

June 9, 2014

Drug Name

Sponsor

Abilify

Otsuka

Abilify

Otsuka

Abilify

Otsuka

Abilify

Otsuka

Camptosar

Pfizer Inc

Caverject

Pharmacia and Upjohn

Cerebyx

Parke Davis

Corvert

Pharmacia and Upjohn

Depacon

Abbvie

Depakene

Abbvie

Depakene

Abbvie

Depakote

Abbvie

Depakote

Abbvie

Depakote Er

Abbvie

Depo-Medrol

Pharmacia and Upjohn

Depo-Provera

Pharmacia and Upjohn

Depo-Provera

Pharmacia and Upjohn

Duloxetine Hydrochloride

Alembic Pharms Ltd

Eraxis

Vicuron

Exforge

Novartis

Exforge Hct

Novartis

Fexofenadine Hydrochloride

Actavis Mid Atlantic

Geodon

Pfizer

Hemabate

Pharmacia and Upjohn

Prostin Vr Pediatric

Pharmacia and Upjohn

Solu-Cortef

Pharmacia and Upjohn

Solu-Medrol

Pharmacia and Upjohn

Sporanox

Janssen Pharms

Sporanox

Janssen Pharms

Vfend

Pfizer

June 8, 2014

Drug Name

Sponsor

Diprivan

Fresenius Kabi Usa

Duragesic-100

Janssen Pharms

Duragesic-12

Janssen Pharms

Duragesic-25

Janssen Pharms

Duragesic-50

Janssen Pharms

Duragesic-75

Janssen Pharms

June 6, 2014

Drug Name

Sponsor

Bunavail106

Biodelivery Sciences Inc

Cefepime and Dextrose In Duplex Container

B Braun

Clinolipid 20%

Baxter Hlthcare

Jublia

Dow Pharm

Nascobal

Par Pharm

Rosuvastatin Calcium

Apotex Corp

Sodium Chloride 3% In Plastic Container

Baxter Hlthcare

Sodium Chloride 5% In Plastic Container

Baxter Hlthcare

Trileptal

Novartis

Trileptal

Novartis

Zithromax

Pfizer

Zithromax

Pfizer

Zithromax

Pfizer

Zithromax

Pfizer

Zithromax

Pfizer

Zithromax

Pfizer


CDER Workshops, Meetings and Conferences

Upcoming

  • FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2014, June 16-17, 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
  • Clinical Development of Drugs for the Prevention of Infections Caused by Staphylococcus aureus in the Health Care Setting. September 5, 2014. Meeting Information

Whats New with CBER


CBER Workshops, Meetings and Conferences

    NONE

Whats New with CDRH

June 16, 2014

June 13, 2014

June 12, 2014

June 11, 2014

June 10, 2014

June 9, 2014

June 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 Parts 310, 314, 329, and 600, 21 CFR Parts 106 and 107
› Wednesday - 21 CFR Part 73

Friday, June 13, 2014

NONE


Thursday, June 12, 2014

 

Proposed Rules

 

Medical Device Classification Procedures; Extension of Comment Period

 

Pages 33711 - 33711 [FR DOC # 2014-13705]

PDF | Text | More

 
 

Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices

 

Pages 33712 - 33712 [FR DOC # 2014-13756]

PDF | Text | More

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies

 

Pages 33755 - 33756 [FR DOC # 2014-13787]

PDF | Text | More

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration

 

Pages 33756 - 33757 [FR DOC # 2014-13788]

PDF | Text | More

 
 

Determination That AZO GANTANOL (Phenazopyridine Hydrochloride, Sulfamethoxazole) Tablet, 100 Milligrams/500 Milligrams, and AZO GANTRISIN (Phenazopyridine Hydrochloride, Sulfisoxazole) Tablet, 50 Milligrams/500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 33757 - 33758 [FR DOC # 2014-13757]

PDF | Text | More

 
 

Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability

 

Pages 33758 - 33759 [FR DOC # 2014-13641]

PDF | Text | More

 
 

Independent Assessment of the Process for the Review of Device Submissions; Final Comprehensive Findings and Recommendations and First Implementation Plan; Correction

 

Pages 33759 - 33760 [FR DOC # 2014-13758]

PDF | Text | More

 
 

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

 

Pages 33760 - 33761 [FR DOC # 2014-13650]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; Arcapta Neohaler

 

Pages 33761 - 33761 [FR DOC # 2014-13638]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; Arctic Front Cryocatheter System

 

Pages 33762 - 33762 [FR DOC # 2014-13640]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; Zuprevo

 

Pages 33763 - 33764 [FR DOC # 2014-13637]

PDF | Text | More

 

Wednesday, June 11, 2014

 

Rules and Regulations

 

Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date

 

Pages 33431 - 33432 [FR DOC # 2014-13524]

PDF | Text | More

 
 

Notices

 

Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish: Availability of Draft Update

 

Pages 33559 - 33562 [FR DOC # 2014-13584]

PDF | Text | More

 
 

Global Unique Device Identification Database; Guidance for Industry; Availability

 

Pages 33568 - 33569 [FR DOC # 2014-13568]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib

 

Pages 33562 - 33563 [FR DOC # 2014-13567]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib

 

Pages 33563 - 33564 [FR DOC # 2014-13566]

PDF | Text | More

 
 

Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Availability

 

Pages 33564 - 33568 [FR DOC # 2014-13544]

PDF | Text | More

 
 

Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products-Recommended Practices; Availability

 

Pages 33569 - 33572 [FR DOC # 2014-13569]

PDF | Text | More

 

Tuesday, June 10, 2014

 

Rules and Regulations

 

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

 

Pages 33072 - 33092 [FR DOC # 2014-13480]

PDF | Text | More

 
 

Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability

 

Pages 33056 - 33057 [FR DOC # 2014-13386]

PDF | Text | More

 
 

Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula

 

Pages 33057 - 33072 [FR DOC # 2014-13384]

PDF | Text | More

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

 

Pages 33196 - 33197 [FR DOC # 2014-13434]

PDF | Text | More

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices

 

Pages 33197 - 33198 [FR DOC # 2014-13435]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; STENDRA

 

Pages 33198 - 33199 [FR DOC # 2014-13444]

PDF | Text | More

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; Xience Prime Ll Everolimus Eluting Coronary Stent System

 

Pages 33199 - 33200 [FR DOC # 2014-13445]

PDF | Text | More

 
 

Draft Guidance for Industry on Providing Submissions in Electronic Format-Postmarketing Safety Reports; Availability

 

Pages 33200 - 33201 [FR DOC # 2014-13479]

PDF | Text | More

 
 

Kidney Health Initiative (R18)

 

Pages 33201 - 33203 [FR DOC # 2014-13443]

PDF | Text | More

 
 

OXIPLEX/SP Gel; FzioMed, Incorporated's Petition for Review of the Food and Drug Administration's Denial of Premarket Approval; Notice of Meeting Cancellation

 

Pages 33203 - 33203 [FR DOC # 2014-13565]

PDF | Text | More

 

Monday, June 9, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Biological Products

 

Pages 32963 - 32964 [FR DOC # 2014-13292]

PDF | Text | More

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Safety Assurance Case

 

Pages 32964 - 32964 [FR DOC # 2014-13291]

PDF | Text | More

 
 

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 32964 - 32965 [FR DOC # 2014-13290]

PDF | Text | More

 


 

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