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.

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,

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). 

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,

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Issued by the FDA

This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission.

The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application.  

FDA Warns of Potential Fatal Adverse Events with the Use of Benzocaine

The FDA is urging manufacturers to stop marketing oral OTC benzocaine products for teething and infants and children younger than 2 years of age.  FDA also warns this is not just a problem with younger age groups.  The product (which is both available for teething and oral spray product for adults) can trigger methemoglobinemia shortly after use and can lead to serious and life-threatening consequences

FDA is asking all manufacturers to review labeling to include warnings about the event as they continue to monitor the situation,

Will Public Shaming Stop the Gaming of the System?

Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval.  The FDA has taken this extraordinary approach to provide greater transparency regarding this issue.  

With Implementation of Requirements Under the Drug Supply Chain Security Act (DSCSA) Rapidly Approaching, FDA issues Guidance on Waivers

Having attended several conferences where the topic of DSCSA has been discussed, and listening to leading vendors (those that provide both hardware and software) opining on how the industry is behind the eight ball in obtaining equipment and full integration, and validation due to long lead times with the number of vendors available, it appeared logical that a document on the availability of waivers might be in the cards.