Exhaustive Extractions

At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.

PQRI and Leachables in Ophthalmic Drug Products

EDITOR’S NOTE:  The author, Dr. Chris Houston, serves on the PQRI-PODP working group as well as a sub-group for Ophthalmics, which is led by iuvo Chief Scientific Officer Dr. Mary Richardson.

 

I recently attended the 3rd FDA/PQRI Conference on Advancing Product Quality held March 22-24, 2017 in Rockville, MD. I was invited to speak about pending output from the PQRI Working Group on Extractables and Leachables in Parenteral and Ophthalmic Drug Products (PODP) with respect to best practices in ophthalmic drug products.

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iuvo BioScience Celebrates Second Anniversary

Last week, iuvo BioScience celebrated our second anniversary.  At times, the two years seem to have flown by in an instant – memories of closing the deal, the Day One presentations in Erie, PA, and Rush, NY, the countless client calls and visits are all as fresh in my mind as if they happened yesterday.  On the other hand, the amount of hard work the entire organization has put into making this a vibrant, growing endeavor makes me wonder “Has it really only been two years since we began this journey?”  A dear friend of mine (and a member of our Board of Directors) calls these “dog years”…referring to the amount of learning and growth that has occurred and feeling like each year is more like seven.

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FDA Publishes List of Over 1,000 Devices Exempted from Premarket Notification Requirements

On March 14, 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that, when finalized, will be exempted from premarket notification requirements (i.e. 510(k)).  

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US and EU Reach Agreement on Pharmaceutical Inspections

On March 2, 2017 the US FDA and the European Medicines Agency announced that the Agencies had completed an exchange of letters amending the 1998 US-EU Mutual Recognition Agreement.  

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VIVAN LifeSciences
Thanks for sharing this type of information this is really useful. I really like it. Keep updating new blogs.
Thursday, 01 June 2017 12:14
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China FDA Launches New Guidelines

Since returning from the country’s New Year Celebration in early February, the China FDA (CFDA) has released a minimum of six new technical review guidelines.  These new guidelines include: 

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FDA Updates Comment Period for new GLP Regulations

On October 31, 2016 the US FDA published a notification in the Federal Register (81 FR 75351) extending the comment period for the Agency’s proposal to amend the good laboratory practice (GLP) regulations for nonclinical studies. This extension was due to requests from interested parties asking that the original 90-day comment period be extended by an additional 90-days to allow sufficient time for the partied to develop meaningful and thoughtful responses to the proposed rule.

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Guest — Josey I.
And just to remind that according to FDA these proposals that are meant to amend the regulations for GLP for nonclinical laborator... Read More
Friday, 14 July 2017 06:33
Ahmed Khan
Nice post...
Thursday, 26 October 2017 09:21
Guest — Allan
Thank you for the information! Sure, these new regulations are reflected in a GLP training that provide an overview of the require... Read More
Friday, 17 November 2017 08:01
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