July 2016

26
Jul

Fiscal Year 2017 GDUFA Fees Announced

The GDUFA Fees for FY 2017 that go into effect October 1, 2016 were published today in the Federal Register (FR) (here). There are some interesting observations relative to the changes in the fees.  Original ANDA application and Prior Approval Supplement fees dropped by almost $6,000 and $3000, respectively.  While the number of ANDAs submitted […]

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21
Jul

Orphan Drug Designations Skyrocket

Orphan Drug Designations (ODD) at the FDA has soared over the past few years with yearly jumps of 30% not uncommon.  In a blog posted today on FDA’s website, Dr. Gayatri Rao, Director for the Office of Orphan Products Development (OOPD) notes that: “In 2014, we saw a 30% increase over the prior year’s record […]

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14
Jul

Tolling of Forfeiture – A Hint of FDA’s Thinking

Ever since the forfeiture provision related to 180-day exclusivity as it relates to the requirement that firms receive approval or tentative approval within 30 months from receipt of an ANDA, there has been some industry confusion regarding the exception of a “change in requirements” and how that might toll the 30-month provision.  Kurt Karst provides […]

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13
Jul

FDA SUPPORTS SHARING FEEDBACK ON INVESTIGATOR CONDUCT DURING INSPECTIONS

If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA).  With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status.  With so much riding on any given inspection, what do you do if problems arise with […]

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