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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)
   

> 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

July 3, 2014

July 2, 2014

July 1, 2014

June 30, 2014

June 27, 2014


Drug Approvals

July 2, 2014

Drug Name

Sponsor

Azor

Daiichi Sankyo

Bendamustine Hydrochloride Injection

Eagle Pharms

Letairis

Gilead

Norpramin

Sanofi Aventis Us

Qualaquin

Mutual Pharm Co Inc

July 1, 2014

Drug Name

Sponsor

Afinitor

Novartis

Afinitor Disperz

Novartis Pharm

Epiduo

Galderma Labs Lp

Iprivask

Marathon Pharms Llc

Linzess

Forest Labs Inc

Lithium Citrate

Roxane

M.V.I. Adult

Hospira

Premphase 14/14

Wyeth Pharms Inc

Prempro

Wyeth Pharms Inc

June 30, 2014

Drug Name

Sponsor

Argatroban

Par Sterile Products

Argatroban

Mylan Institutional

Butrans

Purdue Pharma Lp

Butrans

Purdue Pharma Lp

Chloraprep One-Step

Carefusion

Chloraprep One-Step Frepp

Carefusion

Chloraprep One-Step Sepp

Carefusion

Chloraprep Single Swabstick

Carefusion

Chloraprep Triple Swabstick

Carefusion

Chloraprep With Tint

Carefusion

Faslodex

Astrazeneca

Herceptin

Genentech

Hibiclens

Molnlycke Hlth

Myalept

Amylin Pharms Llc

June 28, 2014

Drug Name

Sponsor

Ozurdex

Allergan

Symbicort

Astrazeneca

June 27, 2014

Drug Name

Sponsor

Afrezza

Mannkind Corp

Ammonia N 13

Univ Tx Md Anderson

Benicar

Daiichi Sankyo

Benicar Hct

Daiichi Sankyo

Buprenorphine Hydrochloride and Naloxone Hydrochloride

Roxane

Buprenorphine Hydrochloride and Naloxone Hydrodhcloride

Roxane

Ceretec

Ge Healthcare

Desmopressin Acetate

Mylan Pharms Inc

Doxorubicin Hydrochloride

Actavis Inc

Eletriptan Hydrobromide

Teva Pharms Usa

Ella

Lab Hra Pharma

Furosemide

Luitpold

Gazyva

Genentech

Lupron Depot

Abbvie Endocrine Inc

Lupron Depot

Abbvie Endocrine Inc

Oxymorphone Hydrochloride

Mallinckrodt Inc

Symlin

Astrazeneca Ab

Symlin

Astrazeneca Ab

Taxol

Hq Spclt Pharma

Tribenzor

Daiichi Sankyo

Vazculep

Eclat Pharms Llc

Virazole

Valeant Pharm Intl


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

July 3, 2014

July 2, 2014

July 1, 2014

June 30, 2014

June 27, 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 -
Thursday - 21 CFR Part 882 and Part 890
Wednesday - 21 CFR Part 558, Parts 510, 520, 522, 529, 556, and 558
Tuesday - 21 CFR Part 514

Friday, July 4, 2014

NONE


Thursday, July 3, 2014

 

Rules and Regulations

 

Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache

 

Pages 37946 - 37948 [FR DOC # 2014-15625]

PDF | Text | More

 
 

Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap

 

Pages 37948 - 37950 [FR DOC # 2014-15626]

PDF | Text | More

 
 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements

 

Pages 38036 - 38037 [FR DOC # 2014-15647]

PDF | Text | More

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antiparasitic Drug Use and Antiparasitic Resistance Survey

 

Pages 38037 - 38039 [FR DOC # 2014-15648]

PDF | Text | More

 

Wednesday, July 2, 2014

 

Rules and Regulations

 

Withdrawal of Approval of Part of a New Animal Drug Application; Procaine Penicillin

 

Pages 37621 - 37622 [FR DOC # 2014-15273]

PDF | Text | More

 
 

New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine

 

Pages 37622 - 37623 [FR DOC # 2014-15274]

PDF | Text | More

 
 

New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address

 

Pages 37617 - 37621 [FR DOC # 2014-15276]

PDF | Text | More

 
 

Proposed Rules

 

Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness

 

Pages 37687 - 37696 [FR DOC # 2014-15371]

PDF | Text | More

 
 

Notices

 

Final Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Availability

 

Pages 37742 - 37743 [FR DOC # 2014-15372]

PDF | Text | More

 
 

Draft Guidance for Industry on Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act; Availability

 

Pages 37743 - 37747 [FR DOC # 2014-15370]

PDF | Text | More

 
 

Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Request for Nominations

 

Pages 37747 - 37750 [FR DOC # 2014-15367]

PDF | Text | More

 
 

Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Revised Request for Nominations

 

Pages 37750 - 37754 [FR DOC # 2014-15373]

PDF | Text | More

 

Tuesday, July 1, 2014

 

Rules and Regulations

 

New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date

 

Pages 37175 - 37175 [FR DOC # 2014-15209]

PDF | Text | More

 
 

Notices

 

Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities Document; Request for Comments

 

Pages 37332 - 37333 [FR DOC # 2014-15374]

PDF | Text | More

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Regarded as Safe Affirmation; Submission of Information to a Master File in Support of Petitions; Electronic Submission

 

Pages 37330 - 37332 [FR DOC # 2014-15384]

PDF | Text | More

 
 

Over-the-Counter Drug Monograph System-Past, Present, and Future; Public Hearing; Reopening of the Comment Period

 

Pages 37332 - 37332 [FR DOC # 2014-15375]

PDF | Text | More

 

Monday, June 30, 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