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,

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.  

505(q) Petitions Still Eating Up Valuable Agency Resources

The FDA has released its required annual report on 505(q) petitions.  Such petitions are characterized by their intent to ask the FDA to either delay approval of an abbreviated new drug application, a 505(b)(2) NDA, or a biosimilar under 351(k) of the Act.  Our good friend Kurt Karst, Director at Hyman, Phelps & McNamara, has outlined the history of 505(q) petitions and the issues addressed in the report here:
He did such a good job that we are not going to delve further into the numbers. 

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.  

From Global Leader to Global Authority!

 

The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals.  While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly generic drug approvals company-wise indicated that Indian companies received a total of 295 out of 763 approvals. 

Got Life? – Check Out the Analytical Procedure Lifecycle

During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures.

There are three lifecycle phases:

  • Procedure Design and Development
  • Procedure Performance Qualification
  • Continuous Procedure Performance Verification

A cornerstone of the design and development phase is the establishment of the Analytical Target Profile (ATP).  

Is the FDA Telling You Something?  Final Bioanalytical Guidance May Point the Way!

Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.”  This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.  For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance,