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Meetings, Notices, & Rule Changes

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>FDA and EU Regulations
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Whats New with CDER

October 24, 2014

October 23, 2014

October 22, 2014

October 21, 2014

October 20, 2014

October 17, 2014


Drug Approvals

October 23, 2014

Drug Name

Sponsor

Abacavir and Lamivudine

Mylan Labs Ltd

Abacavir and Lamivudine

Mylan Labs Ltd

Adrenaclick

Amedra Pharms

Astelin

Meda Pharms

Cancidas

Merck

Dilatrate-Sr

Auxilium Pharms Llc

Finacea

Bayer Hlthcare

Luvox

Ani Pharms

Minocin

Rempex Pharms Inc

Phenylephrine Hydrochloride

West Ward Pharm Corp

Sodium Iodide I 131

Mallinckrodt

Somatuline Depot

Ipsen Pharma

Tudorza Pressair

Forest Labs Inc

Twinject 0.15

Amedra Pharms

Twinject 0.3

Amedra Pharms

Uloric

Takeda Pharms Usa

Zetonna

Takeda Gmbh

October 22, 2014

Drug Name

Sponsor

Aldactazide

Gd Searle Llc

Aldactone

Gd Searle Llc

Ms Contin

Purdue Pharma Lp

Oxycontin

Purdue Pharma Lp

Sotylize

Arbor Pharms Llc

October 21, 2014

Drug Name

Sponsor

Effexor Xr

Wyeth Pharms Inc

Flomax

Boehringer Ingelheim

Paricalcitol

Hospira Inc

Saphris

Forest Labs Inc

Topamax

Janssen Pharms

Topamax

Janssen Pharms

Topamax Sprinkle

Janssen Pharms

October 20, 2014

Drug Name

Sponsor

Absorica

Ranbaxy

Afinitor

Novartis

Boniva

Roche

Cleocin Phosphate

Pharmacia and Upjohn

Dutoprol

Covis Pharma Sarl

Nexium Iv

Astrazeneca

Tarka

Abbvie

Xiaflex

Auxilium Pharms

October 17, 2014

Drug Name

Sponsor

Adrenaclick

Amedra Pharms

Aubagio

Sanofi Aventis Us

Combivent Respimat

Boehringer Ingelheim

Embeda

Alpharma Pharms

Exidine

Xttrium

Sirturo

Janssen Therap

Twinject 0.15

Amedra Pharms

Twinject 0.3

Amedra Pharms


CDER Workshops, Meetings and Conferences

Upcoming

  • The FDA, the Critical Path Institute (C-Path) and the Burroughs Wellcome Fund (BWF) are co-sponsoring the “First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates” – October 28 and 29, 2014 – FDA White Oak Campus – Great Room 1503 A. We would like to invite you all to participate in this workshop on October 28 and 29, 2014. Meeting Information
  • Development and Regulation of Abuse-Deterrent Opioid Medications; Public Meeting, October 30-31, 2014, Sheraton Silver Spring Hotel, 8777 Georgia Avenue, 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
  • FDA Outreach to the Pediatric Cancer Advocacy Community, November 18, 2014, FDA White Oak Campus, Bldg. 31 The Great Room A, Silver Spring, MD. Meeting information

This Weeks Warning Letters:

Letter Issue Date

Company Name

October 10, 2014

IL Pastaio, Inc.

October 10, 2014

Mills Dairy Farm LLC

October 10, 2014

Western/Scott Fetzer Company

October 09, 2014

Bethel Nutritional Consulting, Inc

October 09, 2014

Minerva Dairy Inc

October 09, 2014

Rex L. Jessee

October 08, 2014

Prospect Enterprises, Inc.

October 07, 2014

YoungYou International Inc

September 30, 2014

Stoney Hill Farms

September 26, 2014

http://www.buydiscountcigars.com

September 24, 2014

Beacon Hill Medical Pharmacy, P.C.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences

FDA Industry Meeting: Electronic Postmarket Safety Reporting Updates
October 27, 2014; FDA White Oak Campus - Silver Spring, MD


Whats New with CDRH

October 24, 2014

October 22, 2014

October 21, 2014

October 20, 2014

October 17, 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 -
Wednesday - 21 CFR Part 866

Friday, October 24, 2014

NONE


Thursday, October 23, 2014

 

Proposed Rules

 

Food and Drug Administration Food Safety Modernization Act; Public Meeting

 

Pages 63346 - 63348 [FR DOC # 2014-25261]

PDF | Text

 
 

Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability

 

Pages 63348 - 63349 [FR DOC # 2014-25217]

PDF | Text

 
 

Notices

 

Anti-Infective Drugs Advisory Committee; Notice of Meeting

 

Pages 63407 - 63408 [FR DOC # 2014-25218]

PDF | Text

 

Wednesday, October 22, 2014

 

Rules and Regulations

 

Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance

 

Pages 63034 - 63036 [FR DOC # 2014-25049]

PDF | Text

 
 

Proposed Rules

 

Colorcon, Inc.; Filing of Color Additive Petition

 

Pages 63062 - 63062 [FR DOC # 2014-25089]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations

 

Pages 63127 - 63128 [FR DOC # 2014-25105]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption

 

Pages 63128 - 63129 [FR DOC # 2014-25106]

PDF | Text

 
 

Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry; Availability

 

Pages 63129 - 63130 [FR DOC # 2014-25048]

PDF | Text

 
 

Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

 

Pages 63130 - 63130 [FR DOC # 2014-25033]

PDF | Text

 
 

Seventh Annual Sentinel Initiative; Public Workshop

 

Pages 63130 - 63131 [FR DOC # 2014-25053]

PDF | Text

 
 

Blood Products Advisory Committee; Notice of Meeting

 

Pages 63131 - 63132 [FR DOC # 2014-25067]

PDF | Text

 
 

Determination of Regulatory Review Period for Purposes of Patent Extension; CARBON DIOXIDE LASER

 

Pages 63132 - 63133 [FR DOC # 2014-25032]

PDF | Text

 

Tuesday, October 21, 2014

 

Proposed Rules

 

EMD Millipore Corp.; Filing of Color Additive Petition

 

Pages 62932 - 62932 [FR DOC # 2014-24962]

PDF | Text

 

Monday, October 20, 2014

 

Notices

 

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”

 

Pages 62629 - 62634 [FR DOC # 2014-24797]

PDF | Text

 
 

Kelvin Soto: Debarment Order

 

Pages 62634 - 62635 [FR DOC # 2014-24814]

PDF | Text

 
 

Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Availability

 

Pages 62635 - 62636 [FR DOC # 2014-24796]

PDF | Text

 

Job Board -
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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