16
Oct

First Official Metrics Out for September & OGD Smashes FY ANDA Approval Record – Could It Have Been Better?

For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in […]

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16
Oct

New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program.  The Federal Register Notice (here) announcing the availability of the […]

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08
Oct
California Governor Got it Wrong on Pay-for-Delay Image

California Governor Got it Wrong on Pay-for-Delay!

While California is usually a very progressive state, I believe that Governor Newsom did not quite understand the implications of the bill he signed into law banning pay-for delay patent settlements.  I believe he failed to see that not all pay-for-delay cases are anticompetitive.  According to the Association of Accessible Medicines (AAM) statement about the […]

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04
Oct
OGD Updates August 2019 Metrics Image

OGD Updates August 2019 Metrics

August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications.  Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review […]

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01
Oct

Vasopressin Verdict May be Precedent for Drug Companies Seeking to Protect Approved Products

In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community.  The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]

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27
Sep
stack of one hundred dollars notes

New Fees Announced for Use of Priority-Review Vouchers

In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here).  Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for […]

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20
Sep
The Abuse Deterrent Creep Is On Image

The Abuse Deterrent Creep Is On; FDA Asks for Input on Stimulant Products

Not wanting to really say we saw this coming, but in a blog post in October 2014 (here), we postulated that the abuse-deterrent aspect of other classes of drugs that have abuse potential would likely be become targets as time passed.  In a Federal Register Notice (here), this prediction made in 2014 appears to be […]

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