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More Clarity Sought in FDA’s Inactive Ingredient Database Regarding Drug Delivery Devices

Oct 12, 2016

12. October 2016 FDA and the excipient industry are giving more thought to how the inactive ingredient database (IID) can be improved to better support the development of emerging dosage forms, including drug delivery…

CPhI Worldwide proposes new FDA quality metrics system

Sep 26, 2016

26. September 2016 CPhI Worldwide, organized by UBM EMEA, has announced the findings of part i of the 2016 CPhI Annual Report on potential new approaches to improve quality and manufacturing process in pharmaceutical…

USP-FDA Excipient Workshop

Jul 6, 2016

06. July 2016 February 27, 2017 - February 28, 2017

CFDA Releases the Name List of Excipients Available for Health Food Filing (the First Batch) for…

Jun 4, 2016

04. June 2016 On 17 February 2016, CFDA released the Health Food Raw Materials Directory (the first batch) –Nutrition Supplement Raw Materials Directory. In…

Pharmaceutical Manufacturing in the 21st Century-From Batch to Continuous Manufacturing-An FDA…

Apr 29, 2016

29. April 2016 Webcast Wednesday, 15th June 2016 | 9AM EST More Information and free Registration

Pediatric Study Plans – Draft Guidance FDA

Apr 2, 2016

02. April 2016 Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans…

US FDA backlog holding up revamp of inactive ingredients database

Mar 7, 2016

07. March 2016 The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database (IID) is shaping up to be a huge task, particularly as the…

IPEC Americas & IQ Consortium – FDA meeting to discuss Novel Excipients Initiative…

Nov 7, 2015

07. November 2015 IPEC Americas & IQ Consortium - FDA meeting to discuss Novel Excipients Initiative - June 4, 2015…

FDA evaluation of excipients in generics

Oct 28, 2015

28. October 2015 Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of…

Recent confusion and ongoing actions related to theFDA’s Inactive Ingredient Database (IID) –…

Oct 4, 2015

04. October 2015 Recent confusion and ongoing actions related to the FDA’s Inactive Ingredient Database (IID)…

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