recall square stamp

Valsartan API impurity Leads to Recall of Some Products

Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance.  The FDA announcement states:

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan,

OGD Updates May 2018 Statistics

OGD updated its monthly Activities Report Of the Generic Drug Program FY 2018 for certain statistics that had not yet been posted (here). While we wait for the June 2018 official approval and receipt figures, let’s have a look at some of the interesting May statistics.

OGD reported 8 refuse-to receive (RTR) actions,

Preview of June 2018 Approvals

As far as the available numbers for ANDA approvals and tentative approvals goes, for June, it appears we will have in the neighborhood of 67 full approvals and 6 tentative approvals for the month, more or less in line with what we have seen in the past few months.  These numbers were derived from the FDA All Approvals list (here) and the FDA Approved Drug Products list of daily approvals (here).  

Amendments, business and law concept. Folder Register on desk

Final Guidance on ANDA and Supplement Amendments Hits the Newsstands

Today, as a 4th of July present, and in anticipation of celebratory fireworks, the FDA has issued a final guidance entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (here).  The final guidance explains that the complex tiered amendment classification system of GDUFA I was abandoned to provide a less cumbersome and more straightforward classification of amendment types,

Goal Solution Concept on Blackboard

GDUFA II Regulatory Science initiative – AAM Provides Good Advice

On June 25, 2018, the Association of Accessible Medicines (AAM) submitted comments to Docket FDA-2017-N-6644: Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop and provided some very interesting and relevant comments and suggestions.  The full text of the AAM comments can be found here, but here is a peek into the basket of suggestions.

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 to provide a link to Dr.

Digitalization, Digital Transformation Concept

Bitsy EVA to KASA Grande

Those of us who were around in the Regulatory Affairs field during the late 90s probably remember the glory days of ESD, EVA, and CDOC, following the years of page-stamping in hallways that resembled assembly lines.  Then came EVA, which was part of a system called the Electronic Submission Program, which was in turn, part of a larger strategy for electronic regulatory submission and review at the FDA.

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 is a good start,

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 backlog ANDAs). 

Online file transfer using laptop and digital tablet on blackboard

May Approvals and Receipts and a Bit More

The official numbers of approvals and receipts are out for May 2018.  OGD fully approved 67 ANDAs (one more than last month) and tentatively approved 19 ANDAs (which was six more that we found prior to the final posting) for a total of 86 approval actions.

Given these numbers, if we straight-line the approvals for the year,

Fence separating United States and Mexico

FDA Without Borders! Modernization of Drug Review Office

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research recently proposed changes to CDER’s new drug regulatory program.  The proposals (here) include regulatory and review process changes, as well as organizational restructuring.  The drive behind these changes are to free up resources so that the reviewers have more time to focus on drug development.