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GXPNews.com - FDA News and Announcements August 18 - August 22, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
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Meetings, Notices, & Rule Changes

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Whats New with CDER

August 22, 2014

August 21, 2014

August 20, 2014

August 19, 2014

August 18, 2014

August 15, 2014

 


Drug Approvals

August 21, 2014

Drug Name

Sponsor

Benazepril Hydrochloride and Hydrochlorothiazide

Apotex Inc

Duodote

Meridian Medcl

Elidel

Valeant Bermuda

Eliquis

Bristol Myers Squibb

Kazano

Takeda Pharms Usa

Levocetirizine Dihydrochloride

Apotex Inc

Potassium Chloride

Mylan Pharms Inc

Pralidoxime Chloride

Meridian Medcl Techn

Prepopik

Ferring Pharms As

Retin-A Micro

Valeant Intl

Retin-A-Micro

Valeant Intl

Revatio

Pfizer

Rifampin

Fresenius Kabi Usa

Sandostatin Lar

Novartis

Zoledronic Acid

Akorn Inc

August 20, 2014

Drug Name

Sponsor

Adenoscan

Astellas

Arnuity Ellipta

Glaxosmithkline

Clinolipid 20%

Baxter Hlthcare

Depacon

Abbvie

Depakene

Abbvie

Depakene

Abbvie

Depakote

Abbvie

Depakote

Abbvie

Depakote Er

Abbvie

Fulyzaq

Salix Pharms

Hydroxyzine Hydrochloride

Emcure Pharms Usa

Intelence

Janssen R and D

Levonorgestrel

Perrigo R and D

Polyethylene Glycol 3350;Potassium Chloride;Sodium Bicarbonate;Sodium Chloride and Bisacodyl

Novel Labs Inc

Pristiq

Wyeth Pharms Inc

Radiogardase (Prussian Blue)

Heyl Chemisch

August 19, 2014

Drug Name

Sponsor

Acyclovir

Zydus Pharms Usa Inc

Ammonia N 13

Johns Hopkins Univ

Avinza

King Pharms Llc

Butrans

Purdue Pharma Lp

Cerdelga

Genzyme Corp

Dolophine Hydrochloride

Roxane

Dolophine Hydrochloride

Roxane

Duragesic-100

Janssen Pharms

Duragesic-12

Janssen Pharms

Duragesic-25

Janssen Pharms

Duragesic-50

Janssen Pharms

Duragesic-75

Janssen Pharms

Eliquis

Bristol Myers Squibb

Embeda

Alpharma Pharms

Exalgo

Mallinckrodt Inc

Kadian

Watson Labs Inc

Ms Contin

Purdue Pharma Lp

Mycophenolic Acid

Apotex Inc

Mycophenolic Acid

Apotex Inc

Nucynta Er

Janssen Pharms

Opana Er

Endo Pharms

Opana Er

Endo Pharms

Oxycontin

Purdue Pharma Lp

Targiniq

Purdue Pharma Lp

Zohydro Er

Zogenix Inc

August 18, 2014

Drug Name

Sponsor

Basaglar

Eli Lilly and Co

Cefazolin Sodium

Acs Dobfar

Dexmedetomidine Hydrochloride

Mylan Institutional

Dexmedetomidine Hydrochloride

Par Sterile Products

Docetaxel

Sandoz

Hydromorphone Hydrochloride

Hospira Inc

Neurontin

Pfizer Pharms

Neurontin

Pfizer Pharms

Neurontin

Parke Davis

Rifampin

Emcure Pharms Ltd

Tecfidera

Biogen Idec Inc

August 16, 2014

Drug Name

Sponsor

Actoplus Met

Takeda Pharms Usa

August 15, 2014

Drug Name

Sponsor

Abilify Maintena Kit

Otsuka Pharm Co Ltd

Absorica

Ranbaxy

Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Iclusig

Ariad

Lactated Ringer's In Plastic Container

Hospira

Metoclopramide Hydrochloride

Novel Labs Inc

Olanzapine

Macleods Pharms Ltd

Piperacillin and Tazobactam

Agila Speclts

Plegridy

Biogen Idec Inc

Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira

Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Container

Hospira


CDER Workshops, Meetings and Conferences

Upcoming

  • Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting; September 5, 2014, The DoubleTree by Hilton Hotel, 8727 Colesville Road, Silver Spring, MD 20910. Meeting Information
  • Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments. 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
  • FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
  • FDA’s GDUFA Public Hearing on Policy Development, September 17, 2014
  • FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014; September 18-19, 2014, Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814. Meeting Information
  • FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814. 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

August 14, 2014

Wickliffe Pharmaceutical Inc

August 12, 2014

EWSG, Inc.

August 12, 2014

Hillcrest Dairy

August 11, 2014

Brookhurst Mill

August 11, 2014

Spacelabs Healthcare Inc

August 08, 2014

Dennis Loppnow

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 22, 2014

August 21, 2014

August 20, 2014

August 19, 2014

August 18, 2014

August 15, 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, August 22, 2014

 

Proposed Rules

 

Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications

 

Pages 49727 - 49731 [FR DOC # 2014-19888]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 49778 - 49780 [FR DOC # 2014-19957]

PDF | Text

 
 

Determination That FUSILEV (Levoleucovorin Calcium), Injection, 175 Milligrams/17.5 Milliliters and 250 Milligrams/25 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 49780 - 49781 [FR DOC # 2014-19961]

PDF | Text

 
 

Reopening of Docket and Request for Comments on the Food and Drug Administration Safety and Innovation Act Action Plan

 

Pages 49781 - 49782 [FR DOC # 2014-19881]

PDF | Text

 
 

Evaluation of Sex-Specific Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 49782 - 49783 [FR DOC # 2014-19939]

PDF | Text

 
 

Revamping Microbiological Test Methods for Contact Lenses Products; Public Workshop

 

Pages 49783 - 49784 [FR DOC # 2014-19938]

PDF | Text

 

Thursday, August 21, 2014

 

Proposed Rules

 

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

 

Pages 49465 - 49465 [FR DOC # 2014-19831]

PDF | Text

 

Wednesday, August 20, 2014

 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications

 

Pages 49326 - 49327 [FR DOC # 2014-19695]

PDF | Text

 
 

Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 49327 - 49328 [FR DOC # 2014-19713]

PDF | Text

 
 

Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels

 

Pages 49328 - 49331 [FR DOC # 2014-19696]

PDF | Text

 

Tuesday, August 19, 2014

 

Proposed Rules

 

Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments

 

Pages 49025 - 49027 [FR DOC # 2014-19632]

PDF | Text

 
 

Notices

 

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

 

Pages 49088 - 49089 [FR DOC # 2014-19600]

PDF | Text

 
 

Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Availability

 

Pages 49089 - 49091 [FR DOC # 2014-19577]

PDF | Text

 
 

Food Advisory Committee; Notice of Meeting

 

Pages 49091 - 49091 [FR DOC # 2014-19601]

PDF | Text

 
 

Brain-Computer Interface Devices for Patients With Paralysis and Amputation; Public Workshop; Request for Comments

 

Pages 49091 - 49093 [FR DOC # 2014-19576]

PDF | Text

 

Monday, August 18, 2014

NONE



 

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