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GXPNews.com - FDA News and Announcements June 23 - June 27, 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 27, 2014

June 26, 2014

June 25, 2014

June 24, 2014

June 23, 2014

June 20, 2014


Drug Approvals

June 26, 2014

Drug Name

Sponsor

Cleocin Hydrochloride

Pharmacia and Upjohn

Gattex Kit

Nps Pharms Inc

Valsartan

Ohm Labs Inc

Varithena

Provensis

Zestril

Astrazeneca

June 25, 2014

Drug Name

Sponsor

Cleocin Phosphate In Dextrose 5% In Plastic Container

Pharmacia and Upjohn

Famvir

Novartis

Lisdexamfetamine Dimesylate

Amneal Pharms

Lisdexamfetamine Dimesylate

Mylan Pharms Inc

June 24, 2014

Drug Name

Sponsor

Cardizem

Valeant Intl

Chlorhexidine Gluconate

Sage Prods

Elelyso

Pfizer

Fusilev

Spectrum Pharms

Fusilev

Spectrum Pharms

Imiquimod

Strides Arcolab Ltd

Omega-3-Acid Ethyl Esters

Par Pharm Inc

Paricalcitol

Dr Reddys Labs Ltd

Paricalcitol

Anchen Pharms

Ravicti

Hyperion Therap Inc

Solu-Cortef

Pharmacia and Upjohn

Vfend

Pfizer

Zithromax

Pfizer

Zosyn In Plastic Container

Wyeth Pharms Inc

June 23, 2014

Drug Name

Sponsor

Bromfenac Sodium

Apotex Inc

Enoxaparin Sodium (Preservative Free)

Teva

Lisdexamfetamine Dimesylate

Roxane

Metro I.V. In Plastic Container

B Braun

Morphine Sulfate

Bd Rx

Naphcon-A

Alcon

Omniscan

Ge Healthcare

Pancreaze

Janssen Pharms

Triesence

Alcon

June 20, 2014

Drug Name

Sponsor

Depakote

Abbvie

Dronabinol

Akorn Inc

Humulin R

Lilly

Humulin R Pen

Lilly

Indiclor

Ge Healthcare

Isovue-200

Bracco

Isovue-250

Bracco

Isovue-300

Bracco

Isovue-370

Bracco

Oxycodone Hydrochloride

Lehigh Valley

Retisert

Bausch and Lomb

Sivextro

Cubist Pharms

Sivextro

Cubist Pharms

Tribenzor

Daiichi Sankyo

Trokendi Xr

Supernus Pharms


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 27, 2014

June 26, 2014

June 25, 2014

June 24, 2014

June 23, 2014

June 20, 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 - NONE

Friday, June 27, 2014

 

Notices

 

Privacy Act of 1974; System of Records Notice

 

Pages 36536 - 36537 [FR DOC # 2014-15022]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling Regulations

 

Pages 36529 - 36529 [FR DOC # 2014-15036]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

 

Pages 36529 - 36530 [FR DOC # 2014-15034]

PDF | Text

 
 

Draft Guidance for Industry on Use of Nanomaterials in Food for Animals; Availability

 

Pages 36530 - 36530 [FR DOC # 2014-15030]

PDF | Text

 
 

Global Unique Device Identification Database; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 36530 - 36532 [FR DOC # 2014-15020]

PDF | Text

 
 

Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

 

Pages 36532 - 36533 [FR DOC # 2014-15032]

PDF | Text

 
 

Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives; Availability

 

Pages 36533 - 36534 [FR DOC # 2014-15031]

PDF | Text

 
 

Guidance for Industry: Considering Whether a Food and Drug Administration-Regulated Product Involves the Application of Nanotechnology; Availability

 

Pages 36534 - 36535 [FR DOC # 2014-15033]

PDF | Text

 
 

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

 

Pages 36535 - 36536 [FR DOC # 2014-15021]

PDF | Text

 

Thursday, June 26, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

 

Pages 36318 - 36320 [FR DOC # 2014-14924]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Bioequivalence Data

 

Pages 36320 - 36321 [FR DOC # 2014-14927]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Importer's Entry Notice

 

Pages 36321 - 36321 [FR DOC # 2014-14925]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities

 

Pages 36321 - 36322 [FR DOC # 2014-14977]

PDF | Text

 
 

Small Entity Compliance Guide: Gluten-Free Labeling of Foods; Availability

 

Pages 36322 - 36323 [FR DOC # 2014-14929]

PDF | Text

 
 

Blood Products Advisory Committee; Notice of Meeting

 

Pages 36323 - 36324 [FR DOC # 2014-14922]

PDF | Text

 
 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 36324 - 36324 [FR DOC # 2014-14923]

PDF | Text

 
 

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

 

Pages 36324 - 36325 [FR DOC # 2014-14921]

PDF | Text

 

Wednesday, June 25, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations

 

Pages 36069 - 36070 [FR DOC # 2014-14768]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

 

Pages 36070 - 36071 [FR DOC # 2014-14767]

PDF | Text

 
 

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 36072 - 36072 [FR DOC # 2014-14769]

PDF | Text

 
 

Cooperative Agreement to Support the World Trade Organization's Standards and Trade Development Facility

 

Pages 36073 - 36074 [FR DOC # 2014-14766]

PDF | Text

 

Tuesday, June 24, 2014

 

Proposed Rules

 

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Extension of Comment Period

 

Pages 35711 - 35712 [FR DOC # 2014-14562]

PDF | Text

 

Monday, June 23, 2014

 

Notices

 

Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Novel Influenza A (H7N9) Virus; Availability

 

Pages 35550 - 35558 [FR DOC # 2014-14547]

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