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GXPNews.com - FDA News and Announcements June 30 - July 4, 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 11, 2014

July 10, 2014

July 9, 2014

July 8, 2014

July 7, 2014

July 3, 2014


Drug Approvals

July 10, 2014

Drug Name

Sponsor

Anafranil

Mallinckrodt Llc

Docetaxel

Hospira Inc

Namenda

Forest Labs

Pamelor

Mallinckrodt Inc

Pamelor

Mallinckrodt Llc

Pennsaid

Mallinckrodt Inc

Qnasl

Teva Branded Pharm

Rasuvo

Medac Pharma Inc

Rescula

Sucampo Pharms

Tofranil-Pm

Mallinckrodt Inc

July 9, 2014

Drug Name

Sponsor

Aplenzin

Valeant Bermuda

Cayston

Gilead

Fortical

Upsher Smith

Linzess

Forest Labs Inc

July 8, 2014

Drug Name

Sponsor

Celexa

Forest Labs

Conray

Mallinckrodt

Conray 43

Mallinckrodt

Crestor

Ipr

Frovatriptan Succinate

Mylan Pharms Inc

Quetiapine Fumarate

Mylan Pharms Inc

Valchlor

Actelion Pharms Ltd

Valchlor

Actelion Pharms Ltd

Vantas

Endo Pharm

July 7, 2014

Drug Name

Sponsor

Desvenlafaxine

Alembic Pharms Ltd

Effexor Xr

Wyeth Pharms Inc

Indium In-111 Oxyquinoline

Ge Healthcare

Kerydin

Anacor Pharms Inc

Marqibo Kit

Talon Therap

Telmisartan

Glenmark Generics

Telmisartan

Alembic Ltd

Telmisartan

Mylan Pharms Inc

Telmisartan

Torrent Pharms

July 3, 2014

Drug Name

Sponsor

Aristocort

Sandoz

Aristocort

Sandoz

Aristospan

Sandoz

Benicar

Daiichi Sankyo

Celestone Soluspan

Merck Sharp Dohme

Clonidine Hydrochloride

Caraco

Cyanokit

Merck Sante Sas

Depo-Medrol

Pharmacia and Upjohn

Digoxin

Roxane

Docetaxel

Accord Hlthcare

Dovonex

Leo Pharma As

Fluphenazine Decanoate

Par Sterile Products

Ibuprofen and Phenylephrine Hydrochloride

Perrigo R and D

Ilevro

Alcon Res Ltd

Implanon

Organon Usa Inc

Kenalog-10

Apothecon

Kenalog-40

Apothecon

Namenda Xr

Forest Labs

Nexplanon

Organon Usa Inc

Rapamune

Pf Prism Cv

Solu-Cortef

Pharmacia and Upjohn

Solu-Medrol

Pharmacia and Upjohn

Trelstar

Watson Labs

Trileptal

Novartis

Trileptal

Novartis

Zoledronic Acid

Sun Pharma Global

Zoloft

Pfizer

Zoloft

Pfizer


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:

Letter Issue Date

Company Name

June 30, 2014

Phillips Respironics, Inc.

June 27, 2014

Zarbee's, Inc.

June 27, 2014

Zynex Medical, Inc.

June 11, 2014

Smith & Nephew, Inc.


 

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

July 11, 2014

July 10, 2014

July 9, 2014

July 8, 2014

July 7, 2014

July 3, 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 Part 882
Thursday - 21 CFR Part 1150

Friday, July 11, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007

 

Pages 40107 - 40108 [FR DOC # 2014-16252]

PDF | Text

 
 

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

 

Pages 40108 - 40109 [FR DOC # 2014-16237]

PDF | Text

 
 

Draft Guidance for Industry on Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act; Availability

 

Pages 40109 - 40111 [FR DOC # 2014-16238]

PDF | Text

 
 

Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Amendments and Easily Correctable Deficiencies Under the Generic Drug User Fee Amendments; Availability

 

Pages 40111 - 40112 [FR DOC # 2014-16235]

PDF | Text

 
 

Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Prior Approval Supplements Under the Generic Drug User Fee Amendments of 2012; Availability

 

Pages 40112 - 40113 [FR DOC # 2014-16236]

PDF | Text

 
 

2014 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments

 

Pages 40113 - 40114 [FR DOC # 2014-16207]

PDF | Text

 

Thursday, July 10, 2014

 

Rules and Regulations

 

Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

 

Pages 39302 - 39311 [FR DOC # 2014-16153]

PDF | Text

 

Wednesday, July 9, 2014

 

Notices

 

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036

 

Pages 38910 - 38920 [FR DOC # 2014-15989]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

 

Pages 38905 - 38908 [FR DOC # 2014-15992]

PDF | Text

 
 

Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Availability

 

Pages 38908 - 38908 [FR DOC # 2014-15991]

PDF | Text

 
 

Public Meeting on Patient-Focused Drug Development for Hemophilia A, Hemophilia B, von Willebrand Disease, and Other Heritable Bleeding Disorders

 

Pages 38909 - 38910 [FR DOC # 2014-15990]

PDF | Text

 
 

Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee

 

Pages 38920 - 38921 [FR DOC # 2014-16038]

PDF | Text

 

Tuesday, July 8, 2014

 

Rules and Regulations

 

Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache

 

Pages 38457 - 38459 [FR DOC # 2014-15876]

PDF | Text

 
 

Proposed Rules

 

Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Correction

 

Pages 38478 - 38478 [FR DOC # 2014-15761]

PDF | Text

 
 

Notices

 

Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics; Reopening of the Comment Period

 

Pages 38541 - 38542 [FR DOC # 2014-15809]

PDF | Text

 
 

Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas

 

Pages 38538 - 38539 [FR DOC # 2014-15870]

PDF | Text

 
 

Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis; Public Meeting; Request for Comments

 

Pages 38539 - 38541 [FR DOC # 2014-15871]

PDF | Text

 

Monday, July 7, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

 

Pages 38318 - 38319 [FR DOC # 2014-15810]

PDF | Text

 
 

Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention; Availability

 

Pages 38319 - 38320 [FR DOC # 2014-15801]

PDF | Text

 
 

Pediatric Advisory Committee; Notice of Meeting

 

Pages 38320 - 38321 [FR DOC # 2014-15683]

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