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GXPNews.com - FDA News and Announcements July 21 - July 25, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
   
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> Center for Drug Evaluation & Research (CDER)
> Drug Approvals
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> FDA News & Events
> Biologics Evaluation & Research (CBER)
> Center for Device & Radiology Heath (CDRH)
> Federal Register -
Meetings, Notices, & Rule Changes

>FDA and EU Regulations

Whats New with CDER

July 25, 2014

July 24, 2014

July 23, 2014

July 22, 2014

July 21, 2014

July 18, 2014


Drug Approvals

July 24, 2014

Drug Name

Sponsor

Adderall Xr 10

Shire

Adderall Xr 15

Shire

Adderall Xr 20

Shire

Adderall Xr 25

Shire

Adderall Xr 30

Shire

Adderall Xr 5

Shire

Crixivan

Merck Sharp Dohme

Fortical

Upsher Smith

July 23, 2014

Drug Name

Sponsor

Cardene

Chiesi Usa Inc

Cardene In 0.83% Sodium Chloride In Plastic Container

Chiesi Usa Inc

Cardene In 0.86% Sodium Chloride In Plastic Container

Chiesi Usa Inc

Cardene In 4.8% Dextrose In Plastic Container

Chiesi Usa Inc

Cardene In 5.0% Dextrose In Plastic Container

Chiesi Usa Inc

Edarbi

Arbor Pharms Ireland

Edarbyclor

Arbor Pharms Ireland

Hydrochlorothiazide

Sciegen Pharms Inc

Targiniq Er

Purdue Frederick

Terazol 3

Janssen Pharms

Terazol 3

Janssen Pharms

Terazol 7

Janssen Pharms

Testosterone

Teva Pharms

Zydelig

Gilead Sciences Inc

Zydelig

Gilead Sciences Inc

July 22, 2014

Drug Name

Sponsor

Claritin Hives Relief Reditab

Schering Plough

Claritin Reditabs

Schering Plough

Claritin Reditabs

Schering Plough

Cytoxan

Baxter Hlthcare

Cytoxan (Lyophilized)

Baxter Hlthcare

Desonate

Bayer Hlthcare

Lotensin Hct

Us Pharms Holdings I

Lyophilized Cytoxan

Baxter Hlthcare

Otezla

Celgene Corp

Ryanodex

Eagle Pharms

Solu-Cortef

Pharmacia and Upjohn

Solu-Medrol

Pharmacia and Upjohn

Tacrolimus

Strides Arcolab Ltd

Teveten

Abbvie

Teveten Hct

Abbvie

Xeloda

Hoffmann La Roche

Zoledronic Acid

Sun Pharma Global

July 21, 2014

Drug Name

Sponsor

Brompheniramine Maleate;Pseudoephedrine Hcl;Dextromethorphan Hydrobromide

Vintage Pharms

Fiorinal

Watson Labs Inc

Fiorinal

Watson Labs Inc

Pennsaid

Mallinckrodt Inc

Qvar 40

Teva Branded Pharm

Qvar 80

Teva Branded Pharm

July 18, 2014

Drug Name

Sponsor

Atropine Sulfate

Akorn Inc

Bravelle

Ferring

Brilinta

Astrazeneca Lp

Desvenlafaxine

Teva Pharms Usa

Desvenlafaxine

Sun Pharma Global

Eligard

Tolmar Therap

Eligard

Tolmar Therap

Eligard

Tolmar Therap

Elliotts B Solution

Lukare Medical Llc

Etomidate

Zydus Pharms Usa Inc

Fetzima

Forest Labs Inc

Fluoxetine Hydrochloride

Edgemont Pharms Llc

Kinevac

Bracco

Luvox

Ani Pharms

Mesna

Agila Speclts

Oxytrol

Watson Labs (Utah)

Paxil

Apotex Technologies

Paxil

Apotex Technologies

Paxil Cr

Apotex Technologies

Pexeva

Noven Therap

Prozac

Eli Lilly and Co

Prozac Weekly

Lilly

Remeron

Organon Usa Inc

Remeron Soltab

Organon Usa Inc

Sarafem

Eli Lilly and Co

Stalevo 100

Orion Pharma

Stalevo 125

Orion Pharma

Stalevo 150

Orion Pharma

Stalevo 200

Orion Pharma

Stalevo 50

Orion Pharma

Stalevo 75

Orion Pharma

Symbyax

Lilly

Topicort

Taro

Venlafaxine Hydrochloride

Osmotica Pharm

Vyvanse

Shire Development


CDER Workshops, Meetings and Conferences

Upcoming

  • Public Workshop - The Development of New Antibacterial Products: Charting a Course for the Future (co-sponsored by FDA and NIH).  July 30-31, 2014.
  • 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.
  • 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:

July 18, 2014

PharMEDium Services, LLC

July 16, 2014

National Cigar Store

July 15, 2014

Yellowstone Tobacco Co, LLC.

July 15, 2014

Trivett Sales

July 15, 2014

Graham Shrimp Co., Inc.

July 15, 2014

Dueppengeisser Dairy Company

July 15, 2014

C P Health Products Inc.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

July 25, 2014

July 24, 2014

July 23, 2014

July 22, 2014

July 21, 2014

July 17, 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 -
Friday - 21 CFR Part 876

Friday, July 25, 2014

 

Rules and Regulations

 

Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

 

Pages 43241 - 43246 [FR DOC # 2014-17477]

PDF | Text

 
 

Medical Devices; Gastroenterology-Urology Devices; Classification of the Implantable Transprostatic Tissue Retractor System

 

Pages 43247 - 43249 [FR DOC # 2014-17542]

PDF | Text

 
 

Proposed Rules

 

BASF Corp.; Filing of Food Additive Petition (Animal Use)

 

Pages 43325 - 43326 [FR DOC # 2014-17458]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Potential Tobacco Product Violations Reporting Form

 

Pages 43492 - 43493 [FR DOC # 2014-17543]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Annual Reporting for Custom Device Exemption

 

Pages 43493 - 43493 [FR DOC # 2014-17482]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys

 

Pages 43493 - 43494 [FR DOC # 2014-17590]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry-Pharmacogenomic Data Submissions

 

Pages 43494 - 43494 [FR DOC # 2014-17481]

PDF | Text

 
 

Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Availability

 

Pages 43494 - 43496 [FR DOC # 2014-17588]

PDF | Text

 
 

Clinical Investigator Training Course

 

Pages 43496 - 43497 [FR DOC # 2014-17589]

PDF | Text

 

Thursday, July 24, 2014

NONE


Wednesday, July 23, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding pH of Smokeless Tobacco Products

 

Pages 42797 - 42800 [FR DOC # 2014-17294]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys

 

Pages 42800 - 42800 [FR DOC # 2014-17292]

PDF | Text

 
 

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

 

Pages 42800 - 42801 [FR DOC # 2014-17293]

PDF | Text

 

Tuesday, July 22, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information

 

Pages 42517 - 42518 [FR DOC # 2014-16564]

PDF | Text

 
 

Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments

 

Pages 42518 - 42519 [FR DOC # 2014-17090]

PDF | Text

 
 

Endocrinologic and Metabolic Drug Products Advisory Committee; Notice of Meeting

 

Pages 42519 - 42520 [FR DOC # 2014-17086]

PDF | Text

 

Monday, July 21, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents

 

Pages 42333 - 42337 [FR DOC # 2014-16998]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

 

Pages 42337 - 42338 [FR DOC # 2014-17079]

PDF | Text

 
 

Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

 

Pages 42338 - 42339 [FR DOC # 2014-17081]

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