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GXPNews.com - FDA News and Announcements June 2 - June 6, 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 6, 2014

June 5, 2014

June 4, 2014

June 03, 2014

June 02, 2014

May 30, 2014


Drug Approvals

June 5, 2014

Drug Name

Sponsor

Alsuma

Meridian Medcl

Complera

Gilead Sciences Inc

Exparel

Pacira Pharms Inc

Fioricet W/ Codeine

Watson Labs Inc

Invokana

Janssen Pharms

Lioresal

Medtronic Neuro

Lovaza

Smithkline Beecham

Methoxsalen

Strides Arcolab Ltd

Oxycodone Hydrochloride

Coastal Pharms

Procardia Xl

Pfizer

Risperdal Consta

Janssen Pharms

Septocaine

Deproco

Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Sodium Chloride 0.9% In Plastic Container

Baxter Hlthcare

Suboxone

Reckitt Benckiser

Voltaren

Novartis

Voltaren-Xr

Novartis

June 4, 2014

Drug Name

Sponsor

Amitriptyline Hydrochloride

Accord Hlthcare Inc

Byetta

Astrazeneca Ab

Cefepime In Plastic Container

Baxter Hlthcare

Cevimeline Hydrochloride

Pack Pharms Llc

Elidel

Valeant Bermuda

Fortesta

Endo Pharms

Humalog

Lilly

Humalog Kwikpen

Lilly

Humalog Mix 50/50

Lilly

Humalog Mix 50/50 Kwikpen

Lilly

Humalog Mix 50/50 Pen

Lilly

Humalog Mix 75/25

Lilly

Humalog Mix 75/25 Kwikpen

Lilly

Humalog Mix 75/25 Pen

Lilly

Humalog Pen

Lilly

Humulin 70/30

Lilly

Humulin 70/30 Pen

Lilly

Humulin N

Lilly

Levothyroxine Sodium

Fresenius Kabi Usa

Levothyroxine Sodium

Fresenius Kabi Usa

Prandimet

Novo Nordisk Inc

Prolia

Amgen

Vimpat

Ucb Inc

Vogelxo

Upsher Smith Labs

Xgeva

Amgen

June 3, 2014

Drug Name

Sponsor

Cortenema

Ani Pharms

Increlex

Ipsen Inc

K-Tab

Abbvie

Nithiodote

Hope Pharms

Oxycodone Hydrochloride

Amneal Pharms

Potassium Chloride

Abbvie

Pramipexole Dihydrochloride

Strides Arcolab Ltd

Prolia

Amgen

Vistaril

Pfizer

Vistaril

Pfizer

Votrient

Glaxosmithkline

Xgeva

Amgen

June 2, 2014

Drug Name

Sponsor

Divalproex Sodium

Aurobindo Pharma Ltd

Dymista

Meda Pharms

Kyprolis

Onyx Pharms

Mefenamic Acid

Vintage Pharms Llc

Methadose

Mallinckrodt

Ms Contin

Purdue Pharma Lp

Oxycodone Hydrochloride

Lehigh Valley

Oxycodone Hydrochloride

Vistapharm

Reyataz

Bristol Myers Squibb

Reyataz

Bristol Myers Squibb

May 30, 2014

Drug Name

Sponsor

Abilify Maintena Kit

Otsuka Pharm Co Ltd

Aggrenox

Boehringer Ingelheim

Celecoxib

Teva Pharms

Celecoxib

Mylan Pharma

Celecoxib

Mylan Pharma

Diovan Hct

Novartis

Dostinex

Pharmacia and Upjohn

Eligard

Tolmar Therap

Famotidine

Hi-Tech Pharmacal

Humira

Abbvie Inc

Humira

Abbvie Inc

Jakafi

Incyte Corp

Linezolid

Sandoz

Omidria

Omeros Corp

Tamiflu

Roche

Tamiflu

Roche


CDER Workshops, Meetings and Conferences

Upcoming

  • Public Meeting on Inborn Errors of Metabolism Patient-Focused Drug Development, June 10, 2014,  FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
  • FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2014, June 16-17, 2014. Meeting Information
  • 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

 

Whats New with CBER


CBER Workshops, Meetings and Conferences

    NONE

Whats New with CDRH

June 9, 2014

June 8, 2014

June 4, 2014

June 3, 2014

June 2, 2014

May 30, 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 -
› Monday - 21 CFR Part 878
› Tuesday - 21 CFR Part 878
› Thursday - 21 CFR Part 317
› Friday - 21 CFR Part 17

Friday, June 6, 2014

 

Rules and Regulations

 

Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints; Confirmation of Effective Date

 

Pages 32643 - 32644 [FR DOC # 2014-13165]

PDF | Text

 

Thursday, June 5, 2014

 

Rules and Regulations

 

Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act

 

Pages 32464 - 32481 [FR DOC # 2014-13023]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions

 

Pages 32552 - 32554 [FR DOC # 2014-13037]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements

 

Pages 32554 - 32555 [FR DOC # 2014-13015]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)

 

Pages 32555 - 32556 [FR DOC # 2014-13016]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications

 

Pages 32556 - 32557 [FR DOC # 2014-13041]

PDF | Text

 

Wednesday, June 4, 2014

NONE


Tuesday, June 3, 2014

 

Rules and Regulations

 

Medical Devices; General and Plastic Surgery Devices; Classification of the Powered Surgical Instrument for Improvement in the Appearance of Cellulite

 

Pages 31859 - 31861 [FR DOC # 2014-12814]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables

 

Pages 31943 - 31943 [FR DOC # 2014-12815]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Information From United States Processors That Export to the European Community

 

Pages 31943 - 31944 [FR DOC # 2014-12816]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

 

Pages 31944 - 31944 [FR DOC # 2014-12818]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations

 

Pages 31944 - 31946 [FR DOC # 2014-12819]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food

 

Pages 31946 - 31948 [FR DOC # 2014-12823]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pet Event Tracking Network-State, Federal Cooperation To Prevent Spread of Pet Food Related Diseases

 

Pages 31949 - 31949 [FR DOC # 2014-12813]

PDF | Text

 
 

Compliance Policy Guide Regarding Food Facility Registration-Human and Animal Food; Availability

 

Pages 31949 - 31949 [FR DOC # 2014-12786]

PDF | Text

 
 

Product Development Under the Animal Rule, Revised Draft Guidance for Industry; Availability

 

Pages 31950 - 31951 [FR DOC # 2014-12807]

PDF | Text

 
 

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

 

Pages 31951 - 31952 [FR DOC # 2014-12808]

PDF | Text

 

Monday, June 2, 2014

 

Rules and Regulations

 

General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products

 

Pages 31205 - 31214 [FR DOC # 2014-12546]

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