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GXPNews.com - FDA News and Announcements June 16 - June 20, 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 20, 2014

June 19, 2014

June 18, 2014

June 17, 2014

June 16, 2014

June 13, 2014


Drug Approvals

June 19, 2014

Drug Name

Sponsor

Androderm

Watson Labs

Androgel

Abbvie

Androgel

Abbvie

Androgel

Abbvie

Androgel

Abbvie

Aveed

Endo Pharms Inc

Axiron

Eli Lilly and Co

Bromfenac Sodium

Apotex Inc

Combivent Respimat

Boehringer Ingelheim

Delatestryl

Endo Pharms

Delsym

Reckitt Benckiser

Depacon

Abbvie

Depakene

Abbvie

Depakene

Abbvie

Depakote

Abbvie

Depakote

Abbvie

Depakote Er

Abbvie

Fallback Solo

Lupin Ltd

Fortesta

Endo Pharms

Omnipaque 140

Ge Healthcare

Omnipaque 180

Ge Healthcare

Omnipaque 210

Ge Healthcare

Omnipaque 240

Ge Healthcare

Omnipaque 300

Ge Healthcare

Omnipaque 350

Ge Healthcare

Omnipaque 70

Ge Healthcare

Striant

Auxilium Pharms Llc

Testim

Auxilium Pharms

Testosterone

Teva Pharms

Testosterone

Perrigo Israel

Testosterone

Perrigo Israel

Thalomid

Celgene

June 18, 2014

Drug Name

Sponsor

Acyclovir

Amneal Pharms

Bloxiverz

Eclat Pharms Llc

Boniva

Hoffmann La Roche

Boniva

Roche

Chlorothiazide Sodium

Mylan Institutional

Hycamtin

Glaxo Wellcome

Merrem

Astrazeneca

Micronor

Janssen Pharms

Nuvaring

Organon Usa Inc

Oxaliplatin

Jiangsu Hengrui Med

Pitocin

Par Sterile Products

Truvada

Gilead

Vpriv

Shire Human Genetic

Vpriv

Shire Human Genetic

June 17, 2014

Drug Name

Sponsor

Advair Diskus 100/50

Glaxo Grp Ltd

Advair Diskus 250/50

Glaxo Grp Ltd

Advair Diskus 500/50

Glaxo Grp Ltd

Advair Hfa

Glaxo Grp Ltd

Altabax

Glaxo Grp Ltd

Beconase Aq

Glaxosmithkline

Exalgo

Mallinckrodt Inc

Flonase

Glaxosmithkline

Flovent Diskus 100

Glaxo Grp Ltd

Flovent Diskus 250

Glaxo Grp Ltd

Flovent Diskus 50

Glaxo Grp Ltd

Flovent Hfa

Glaxo Grp Ltd

Reclast

Novartis

Technescan

Mallinckrodt

Ventolin Hfa

Glaxo Grp Ltd

Veramyst

Glaxosmithkline

Zometa

Novartis

June 16, 2014

Drug Name

Sponsor

Bio-Tropin

Ferring

Daptomycin

Hospira Inc

Noxafil

Schering

Nutropin Aq

Genentech

Nutropin Aq Pen

Genentech

Prolia

Amgen

Saizen

Emd Serono

Serostim

Emd Serono

Serostim Lq

Emd Serono

Tev-Tropin

Ferring

Xgeva

Amgen

June 13, 2014

Drug Name

Sponsor

Alli

Glaxosmithkline Cons

Azor

Daiichi Sankyo

Benicar

Daiichi Sankyo

Benicar Hct

Daiichi Sankyo

Bicnu

Emcure Pharms Ltd

Codeine Sulfate

Lannett Holdings Inc

Comtan

Orion Pharma

Differin

Galderma Labs Lp

Jetrea

Thrombogenics, Inc

Kalydeco

Vertex Pharms

Lymphoseek Kit

Navidea Biopharms

Renova

Valeant Intl

Risedronate Sodium

Teva Pharms

Sporanox

Janssen Pharms

Talc

Bryan

Tribenzor

Daiichi Sankyo

Venofer

Luitpold


CDER Workshops, Meetings and Conferences

Upcoming

  • 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
  • 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

Whats New with CBER


CBER Workshops, Meetings and Conferences

    NONE

Whats New with CDRH

June 20, 2014

June 19, 2014

June 18, 2014

June 17, 2014

June 16, 2014

June 13, 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 Part 872
> Monday - 21 CFR Part 878

Friday, June 20, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

 

Pages 35357 - 35358 [FR DOC # 2014-14473]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds

 

Pages 35358 - 35360 [FR DOC # 2014-14472]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles

 

Pages 35360 - 35361 [FR DOC # 2014-14471]

PDF | Text

 
 

Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Availability

 

Pages 35361 - 35362 [FR DOC # 2014-14470]

PDF | Text

 
 

Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing

 

Pages 35362 - 35363 [FR DOC # 2014-14447]

PDF | Text

 

Thursday, June 19, 2014

 

Notices

 

Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six Abbreviated New Drug Applications

 

Pages 35170 - 35172 [FR DOC # 2014-14288]

PDF | Text

 
 

Draft Guidance for Industry on Uncomplicated Gonorrhea: Developing Drugs for Treatment; Availability

 

Pages 35172 - 35173 [FR DOC # 2014-14303]

PDF | Text

 

Wednesday, June 18, 2014

 

Rules and Regulations

 

Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

 

Pages 34623 - 34625 [FR DOC # 2014-14216]

PDF | Text

 
 

Proposed Rules

 

Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act; Reopening of Comment Period

 

Pages 34668 - 34668 [FR DOC # 2014-14213]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, Exemptions From Substantial Equivalence Requirements

 

Pages 34756 - 34758 [FR DOC # 2014-14253]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Event Program for Medical Devices (Medical Product Safety Network)

 

Pages 34758 - 34759 [FR DOC # 2014-14252]

PDF | Text

 
 

Draft Guidance for Industry on Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Availability

 

Pages 34759 - 34760 [FR DOC # 2014-14220]

PDF | Text

 
 

Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability

 

Pages 34760 - 34763 [FR DOC # 2014-14221]

PDF | Text

 
 

Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

 

Pages 34763 - 34764 [FR DOC # 2014-14215]

PDF | Text

 

Tuesday, June 17, 2014

NONE


Monday, June 16, 2014

 

Rules and Regulations

 

Medical Devices; General and Plastic Surgery Devices; Classification of the Nonabsorbable Expandable Hemostatic Sponge for Temporary Internal Use

 

Pages 34222 - 34224 [FR DOC # 2014-13905]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Food and Drug Administration-Regulated Products Used in Animals

 

Pages 34312 - 34313 [FR DOC # 2014-13929]

PDF | Text

 
 

Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 34313 - 34314 [FR DOC # 2014-13906]

PDF | Text

 
 

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6 on Uniformity of Dosage Units General Chapter; Availability

 

Pages 34314 - 34315 [FR DOC # 2014-13908]

PDF | Text

 
 

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

 

Pages 34315 - 34317 [FR DOC # 2014-13907]

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