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IPEC-Americas Joins Other Industry Associations in Providing Initial Feedback on FDA’s Quality…

Sep 19, 2015

19. September 2015 IPEC-Americas Joins Other Industry Associations in Providing Initial Feedback on FDA's Quality Metrics Draft Guidance at Aug. 24 Meeting …

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Industry Responds to FDA Metrics Program

Sep 15, 2015

08. September 2015 After nearly three years of workshops, white papers, and pilot tests, one might expect some agreement between FDA and manufacturers of drugs and biologics on how to measure the quality and reliability of…

IPEC-Americas Representatives Continue Discussions with FDA IID Working Group, Respond to Issues…

Sep 7, 2015

07. September 2015 Discussions with FDA IID Working Group Representatives from IPEC-Americas recently met with FDA's Office of Generic Drugs (OGD) Inactive Ingredient…

IPEC-Americas Presents Two Key Excipient Topics at FDA GDUFAMeetingPart I of 2-Part Series – Novel…

Jul 22, 2015

22. July 2015 On June 15, 2015, FDA held a public meeting to seek input on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). IPEC-Americas…

IPEC calls on FDA to establish new review process for novel excipients

Jul 22, 2015

22. July 2015 By Zachary Brennan+, 22-Jul-2015 As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory…

Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with…

May 27, 2015

27. May 2015 http://multibriefs.com/briefs/ipec/ImplementigtheANSINSFIPECstandardforIPEC_2.pdf…

IPEC says confusion around FDA review of excipients could delay ANDA review cycles

May 5, 2015

05. May 2015 By Zachary Brennan+Zachary Brennan, 05-May-2015 Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient…

FDA calls on manufacturers to begin switch from batch to continuous production

May 4, 2015

04. May 2015 By Zachary Brennan+, 01-May-2015 Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma…

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IPEC-Americas Publishes Position Paper on FDA Inactive Ingredient Database

Apr 23, 2015

23. April 2015 Issues related to inaccurate and incomplete information on excipients referenced in the U.S. FDA Inactive Ingredient Database (IID) and FDA policies and guidance related to the review of inactive…

List of US FDA DMF Type IV as per 1st quarter 2015

Apr 23, 2015

23. April 2015 List of US FDA DMF Type IV as per 1st quarter 2015 List of active DMF Type IV as per 1st…

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