June 2018

29
Jun
Quality Concept: Arrow of A Compass Pointing Quality Text

Quality Metrics- The Next Step

Over a decade ago, the FDA issued a final report on Pharmaceutical Quality for the Twenty-First Century. As time moved forward, this led to the FDA’s Center for Drug Evaluation and Research through the creation of the Office of Pharmaceutical Quality, to launch “FDA Pharmaceutical Quality Oversight: One Quality Voice” (here), which attempts to develop […]

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21
Jun
Waiver legal concept

Update of 2011 Draft Guidance on Waivers, Reductions, and Refunds of PDUFA Fees

The revised version of the 2011 Draft Guidance (here) “describes (1) the types of waivers, refunds, and reductions available under the user fee provisions of the FD&C Act, (2) the procedures for requesting waivers, refunds, or reductions, and (3) the process for requesting a reconsideration, or appeal of an FDA decision.  The Draft Guidance also […]

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20
Jun

CDER Outlines Actions on Drug Shortages

Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages.  Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary […]

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20
Jun

50 Bills Moving through Congress on Opioid Epidemic – Is It Possible to Legislate Behavior?

The Hill reports (here) that there are close to 50 Bills pending before Congress that are expecting action by the end of the week, to help address the opioid epidemic.  It is the hope that a comprehensive package will be put together and ultimately be passed into law. Providing a legislative foundation to the cause […]

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19
Jun
Headline shortages

New Drug Shortages Drop in 2017, But Tell That to the Patients!

The Report on Drug Shortages for Calendar Year 2017 (here), which is required by Section 506C-1 of the Federal Food, Drug and Cosmetic Act, issued last Thursday, and describes some real progress in the drug shortage arena. The report notes that “][d]uring 2017, FDA helped prevent 145 potential new shortages, and there were 39 new […]

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13
Jun
empty cockpit of vehicle

OGD Releases 2nd Quarter Generic Drug Snapshot on Its Dashboard

The current Submission Status Snapshot which was published yesterday (here) describes the current OGD workload. It is broken down into two major charts, the Pre GDUFA Year 3 applications and the current Total OGD Workload chart.  Why?  Remember that pre-year 3 applications did not have goal dates like those that were submitted pre-GDUFA (the old […]

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