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GXPNews.com - FDA News and Announcements July 28 - August 1, 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

August 1, 2014

July 31, 2014

July 30, 2014

July 29, 2014

July 28, 2014

July 25, 2014


Drug Approvals

July 31, 2014

Drug Name

Sponsor

Adrenalin

Par Sterile Products

Estradiol

Novartis

Farxiga

Astrazeneca Ab

Fortesta

Endo Pharms

Gilotrif

Boehringer Ingelheim

Hectorol

Genzyme Corp

Humalog

Lilly

Humalog Kwikpen

Lilly

Humalog Pen

Lilly

Loestrin Fe 1/20

Warner Chilcott

Megace Es

Par Pharm

Pegintron

Schering

Pegintron

Schering

Somavert

Pharmacia and Upjohn

Striverdi Respimat

Boehringer Ingelheim

Sylatron

Schering

Victoza

Novo Nordisk Inc

Vivelle-Dot

Novartis

Zanosar

Teva Pharms Usa

Zelapar

Valeant Pharm Intl

July 30, 2014

Drug Name

Sponsor

Absorica

Ranbaxy

Amoxil

Dr Reddys Labs Inc

Belviq

Eisai Inc

Canasa

Forest Labs Inc

Diclegis

Duchesnay

Excedrin (Migraine)

Novartis

Humatrope

Lilly

Iclusig

Ariad

Jentadueto

Boehringer Ingelheim

Quelicin

Hospira

Quelicin Preservative Free

Hospira

July 29, 2014

Drug Name

Sponsor

Dextromethorphan Hydrobromide and Quinidine Sulfate

Par Pharm Inc

Epinephrine

Belcher Pharms

Kalydeco

Vertex Pharms

Korlym

Corcept Therap

Natrecor

Scios Llc

Prandimet

Novo Nordisk Inc

Viokace

Forest Labs Inc

July 28, 2014

Drug Name

Sponsor

Anafranil

Mallinckrodt Llc

Aromasin

Pharmacia and Upjohn

Caduet

Pfizer

Cardura

Pfizer

Cardura Xl

Pfizer

Celebrex

Gd Searle

Chantix

Pfizer Inc

Detrol

Pharmacia and Upjohn

Detrol La

Pharmacia and Upjohn

Diflucan

Pfizer

Diflucan

Pfizer

Diflucan In Dextrose 5% In Plastic Container

Pfizer

Diflucan In Sodium Chloride 0.9%

Pfizer

Diflucan In Sodium Chloride 0.9% In Plastic Container

Pfizer

Exemestane

Eirgen Pharma Ltd

Imbruvica

Pharmacyclics Inc

Korlym

Corcept Therap

Minipress

Pfizer

Norvasc

Pfizer

Otezla

Celgene Corp

Pamelor

Mallinckrodt Inc

Pamelor

Mallinckrodt Llc

Taclonex

Leo Pharma As

Taclonex

Leo Pharma As

Technescan Mag3

Mallinckrodt

Tofranil-Pm

Mallinckrodt Inc

Vascepa

Amarin Pharms

Victrelis

Merck Sharp Dohme

Zyvox

Pharmacia and Upjohn

Zyvox

Pharmacia and Upjohn

Zyvox

Pharmacia and Upjohn

July 25, 2014

Drug Name

Sponsor

Acticlate

Aqua Pharms

Adrenaclick

Amedra Pharms

Alinia

Romark

Apokyn

Us Worldmeds

Azactam In Plastic Container

Bristol Myers Squibb

Biaxin

Abbvie

Biaxin

Abbvie

Biaxin Xl

Abbvie

Children's Claritin

Schering Plough

Habitrol

Novartis

Habitrol

Novartis

Jakafi

Incyte Corp

Lastacaft

Allergan

Mestinon

Valeant Pharms Llc

Pradaxa

Boehringer Ingelheim

Prevantics Maxi Swabstick

Prof Dspls

Prevantics Swab

Prof Dspls

Prevantics Swabstick

Prof Dspls

Twinject 0.15

Amedra Pharms

Twinject 0.3

Amedra 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.
  • 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
  • Patient-Focused Drug Development Public Meeting and Scientific workshop on Female Sexual Dysfunction, October 27-28, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. 20993. Meeting information

This Weeks Warning Letters:

July 22, 2014

Hoke Farms

July 22, 2014

K-Fat Inc.

July 21, 2014

Med-Mizer, Inc.

July 21, 2014

Smoker Friendly International LLC

July 17, 2014

Klein Laboratories, Inc.

July 17, 2014

Opada Alzohalli, M.D.

July 17, 2014

Schindele Enterprises dba Midwest Wholesale

 

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 1, 2014

July 31, 2014

July 30, 2014

July 29, 2014

July 28, 2014

July 25, 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 Parts 520, 522, 529, and 558

Friday, August 1, 2014

 

Notices

 

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2015

 

Pages 44787 - 44792 [FR DOC # 2014-18110]

PDF | Text

 
 

Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2015

 

Pages 44792 - 44795 [FR DOC # 2014-18178]

PDF | Text

 
 

Biosimilar User Fee Rates for Fiscal Year 2015

 

Pages 44795 - 44797 [FR DOC # 2014-18112]

PDF | Text

 
 

Outsourcing Facility Fee Rates for Fiscal Year 2015

 

Pages 44805 - 44807 [FR DOC # 2014-18111]

PDF | Text

 
 

Prescription Drug User Fee Rates for Fiscal Year 2015

 

Pages 44807 - 44811 [FR DOC # 2014-18113]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

 

Pages 44779 - 44780 [FR DOC # 2014-18195]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review

 

Pages 44780 - 44782 [FR DOC # 2014-18168]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations

 

Pages 44782 - 44785 [FR DOC # 2014-18197]

PDF | Text

 
 

Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle

 

Pages 44785 - 44787 [FR DOC # 2014-18109]

PDF | Text

 
 

Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2015

 

Pages 44797 - 44800 [FR DOC # 2014-18108]

PDF | Text

 
 

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2015

 

Pages 44800 - 44803 [FR DOC # 2014-18172]

PDF | Text

 
 

Draft Guidance for Industry on Cell-Based Products for Animal Use; Availability

 

Pages 44803 - 44804 [FR DOC # 2014-18134]

PDF | Text

 
 

Intent To Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 44804 - 44805 [FR DOC # 2014-18198]

PDF | Text

 

Thursday, July 31, 2014

 

Rules and Regulations

 

New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin

 

Pages 44277 - 44278 [FR DOC # 2014-17912]

PDF | Text

 

Wednesday, July 30, 2014

 

Notices

 

Medical Device User Fee Rates for Fiscal Year 2015

 

Pages 44178 - 44184 [FR DOC # 2014-17902]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Safety Communication Readership Survey

 

Pages 44177 - 44177 [FR DOC # 2014-17891]

PDF | Text

 
 

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Guidance for Industry and Food and Drug Administration Staff

 

Pages 44177 - 44178 [FR DOC # 2014-17901]

PDF | Text

 
 

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

 

Pages 44184 - 44185 [FR DOC # 2014-17890]

PDF | Text

 

Tuesday, July 29, 2014

 

Notices

 

Nonprescription Drugs Advisory Committee; Notice of Meeting

 

Pages 44041 - 44042 [FR DOC # 2014-17710]

PDF | Text

 
 

Nonprescription Drugs Advisory Committee; Notice of Meeting

 

Pages 44042 - 44043 [FR DOC # 2014-17711]

PDF | Text

 

Monday, July 28, 2014

 

Notices

 

Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket

 

Pages 43751 - 43753 [FR DOC # 2014-17691]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Reports of Corrections and Removals

 

Pages 43751 - 43751 [FR DOC # 2014-17633]

PDF | Text

 
 

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Generic Drug User Fee Cover Sheet

 

Pages 43751 - 43751 [FR DOC # 2014-17712]

PDF | Text

 
 

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 43753 - 43754 [FR DOC # 2014-17666]

PDF | Text

 
 

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

 

Pages 43755 - 43755 [FR DOC # 2014-17665]

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