The Lachman Blog

09
Nov

Learning the GDUFA II Language

Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA.  It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference […]

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07
Nov

Do You Have a Story to Tell?

Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right.  At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter, […]

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07
Nov

Improving Health of the Least of Us for the Benefit of All of Us – A Guest Blog

My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network.  Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends, […]

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30
Oct

Do You Owe the FDA Money?

Remember certain GDUFA fees were assessed on October 1, 2017 including the new FDA program fee and establishment fees.  The FDA published arrears lists today and there are a lot of folks on those lists.  If there is an error or if you need to pay the fee you should either rectify the situation quickly […]

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