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,

Outsourcing and Compounding Pharmacies Under FDA Scrutiny for Topical Pain Products, But That’s Not All

FDA Commissioner Scott Gottlieb issued a statement (here) on the Agency’s continuing position related to compounded drugs for patients that cannot use an FDA approved product.  However, the bent taken in his statement leans more towards the issues of safety and efficacy, while he points to the Department of Justice’s (DOJ) recent healthcare fraud enforcement actions related to the use of multi-component compounded products thought to artificially increase billing rates for these compounded products.

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.