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GXPNews.com - FDA News and Announcements July 14 - July 18, 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
> Meetings and Conferences
> Warning Letters
> 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 18, 2014

July 17, 2014

July 16, 2014

July 15, 2014

July 14, 2014


Drug Approvals

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

July 17, 2014

Drug Name

Sponsor

Abacavir Sulfate; Lamivudine

Teva Pharms

Adagen

Sigma Tau

Brintellix

Takeda Pharms Usa

Cymbalta

Lilly

Desyrel

Apothecon

Epi E Z Pen Jr

Mylan Speclt

Epipen

Mylan Speclt

Epipen E Z Pen

Mylan Speclt

Epipen Jr.

Mylan Speclt

Forfivo Xl

Edgemont Pharms Llc

Oleptro

Angelini Pharma

Pristiq

Wyeth Pharms Inc

Ropivacaine Hydrochloride

Navinta Llc

Sinemet

Merck Sharp Dohme

Sinemet Cr

Merck Sharp Dohme

Surmontil

Odyssey Pharms

Tudorza Pressair

Forest Labs Inc

Vivactil

Teva Womens

Wellbutrin

Glaxosmithkline

Wellbutrin Sr

Glaxosmithkline

Zosyn In Plastic Container

Wyeth Pharms Inc

July 16, 2014

Drug Name

Sponsor

Hexadrol

Organon Usa Inc

Khedezla

Osmotica Pharm Corp

Promacta

Glaxosmithkline

Viibryd

Forest Labs Inc

July 15, 2014

Drug Name

Sponsor

Arixtra

Agi

Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide

Paddock Labs

Demser

Aton Pharma Vpna

Excedrin (Migraine)

Novartis

Sancuso

Prostrakan Inc

Sodium Lactate In Plastic Container

Hospira

Solodyn

Medicis

Trelstar

Watson Labs

Trelstar

Watson Labs

July 14, 2014

Drug Name

Sponsor

Fluocinonide

Glenmark Generics

Fluocinonide

Taro Pharma

Fluocinonide

Fougera Pharms

Infuvite Pediatric (Pharmacy Bulk Package)

Sandoz

Omnitrope

Sandoz

Ritalin

Novartis

Sinequan

Pfizer

Sinequan

Pfizer

July 11, 2014

Drug Name

Sponsor

Atripla

Gilead

Bravelle

Ferring

Complera

Gilead Sciences Inc

Kadcyla

Genentech

Menopur

Ferring

Rythmol

Glaxosmithkline Llc

Rythmol Sr

Glaxosmithkline Llc

Trelstar

Watson Labs

Trelstar

Watson Labs

Trelstar

Watson Labs

Truvada

Gilead

Vpriv

Shire Human Genetic

Vpriv

Shire Human Genetic

Wellbutrin Xl

Valeant Intl


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 09, 2014

www.200cigarettes.biz

July 07, 2014

JCB Labs LLC

July 07, 2014

Trifarma S.p.A.

July 03, 2014

Easy Moon, Inc. - Ramona Egg Ranch

July 03, 2014

Walker's Food Products Co

July 02, 2014

Central Soyfoods

July 02, 2014

Sterling Heights Dairy Farm LLC

July 02, 2014

Ventlab LLC

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

July 17, 2014

July 16, 2014

July 15, 2014

July 14, 2014

July 11, 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 106 and 107

Friday, July 18, 2014

 

Notices

 

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

 

Pages 42022 - 42023 [FR DOC # 2014-16931]

PDF | Text

 

Thursday, July 17, 2014

 

Notices

 

Site Tours Program

 

Pages 41698 - 41699 [FR DOC # 2014-16794]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Testing as Used by the Food and Drug Administration Center for Tobacco Products

 

Pages 41696 - 41697 [FR DOC # 2014-16795]

PDF | Text

 
 

Food Advisory Committee; Notice of Meeting

 

Pages 41697 - 41698 [FR DOC # 2014-16777]

PDF | Text

 
 

AbbVie Inc., et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen

 

Pages 41699 - 41700 [FR DOC # 2014-16820]

PDF | Text

 

Wednesday, July 16, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

 

Pages 41579 - 41580 [FR DOC # 2014-16709]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exception From General Requirements for Informed Consent

 

Pages 41580 - 41581 [FR DOC # 2014-16672]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

 

Pages 41582 - 41583 [FR DOC # 2014-16589]

PDF | Text

 
 

Food and Drug Administration Third Annual Patient Network Meeting; Under the Microscope: Pediatric Drug Development

 

Pages 41583 - 41584 [FR DOC # 2014-16714]

PDF | Text

 
 

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

 

Pages 41584 - 41584 [FR DOC # 2014-16671]

PDF | Text

 
 

Small Entity Compliance Guide: Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Availability

 

Pages 41585 - 41585 [FR DOC # 2014-16590]

PDF | Text

 

Tuesday, July 15, 2014

 

Rules and Regulations

 

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

 

Pages 41127 - 41127 [FR DOC # 2014-16476]

PDF | Text

 
 

Proposed Rules

 

Confidentiality of Interim Results in Cardiovascular Outcome Safety Trials; Public Hearing; Request for Comments

 

Pages 41149 - 41152 [FR DOC # 2014-16374]

PDF | Text

 
 

Notices

 

Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] With Different Technological Characteristics; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 41289 - 41290 [FR DOC # 2014-16565]

PDF | Text

 
 

Draft Guidance for Industry on Substantial Equivalence Reports; Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product; Availability

 

Pages 41292 - 41292 [FR DOC # 2014-16562]

PDF | Text

 
 

Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability

 

Pages 41291 - 41292 [FR DOC # 2014-16492]

PDF | Text

 

Monday, July 14, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey, as Used by the Food and Drug Administration

 

Pages 40760 - 40761 [FR DOC # 2014-16384]

PDF | Text

 
 

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

 

Pages 40761 - 40762 [FR DOC # 2014-16358]

PDF | Text

 
 

Dermatologic and Ophthalmic Drugs Advisory Committee Meeting

 

Pages 40762 - 40763 [FR DOC # 2014-16359]

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