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 in FY 2015 was the lowest ever during the first 5 years of GDUFA,

MHRA Draft GxP Data Integrity

 The integrity of all GxP data used to ensure the quality and efficacy of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health.  To that point, the MHRA has published a draft version for consultation of a guidance titled “MHRA GxP Data Integrity Definitions and Guidance for Industry”    This draft is intended to update and broaden the scope of the existing March 2015 “MHRA Data Integrity Definitions and Guidance for Industry” to all GxP data. 

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 number.

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 some insight into a recent case in his FDA Law Blog (here) that may shed some light on the situation.


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 the investigator or analyst?

Draft Guidance on Changes to ANDA Labeling Where the RLD Has Been Removed from the Market

FDA issued a draft Guidance titled “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn” (here)  describing how and what type of changes FDA anticipates ANDA applicants to make in such situations.

FDA makes clear in the Guidance that it the Guidance does not have applicability to the FDA’s Proposed Labeling Rule for generic drugs,

Additional Guidance for Compounders of Commercially Available Copies of Products

Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products.  The two documents, one for compounding pharmacies under Section 503A of the Act (here) and the other that addresses outsourcing facilities under Section 503B of the Act (here) describe FDA’s view of how the issue of compounding essentially commercially available drug products will be evaluated under the Act and when such products might be subject to FDA enforcement action. 

Medication Assisted Treatment (MAT) Patient Treatment Limits Final Rule

On June 5, 2016 we posted a blog (here) outlining Congressional support for an increase in the number of patients that practitioners can treat for substance abuse with designated medications.  Tomorrow, HHS will publish a 112-page Final Rule (here) outlining how the phase in of an increase in the number of patients that a provider will be able to treat and monitor will be accomplished.