Sit! – Stay! – No IND Needed as Part of Guidance Document is Stayed

Last Friday, FDA published a Notice in the Federal Register (here) relative to staying a portion of its September 2013 Guidance Document titled Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND.  The Agency indicated that, based on comment received on various sections of the final Guidance,

OGD Revision of BE Guidance – What Does it Mean for Product Development and Approved Products?

How does the Office of Generic Drugs (OGD) make a determination to revise an existing bioequivalence (BE) guidance? What happens to the requirements for drug product under development or those products that are approved when a BE guidance is revised? These questions were addressed by Dr. Robert Lionberger and Dr. Larissa Lapteva in a session at the GPhA Fall Tech Conference.

Controlled Correspondence Responses Beat GDUFA Goals

As you know, the issue of controlled correspondence has historically been a contentious issue between the Office of Generic Drugs and the generic industry mostly related to timing of the response. The situation is not different today but the contention addressed today is more about the new definition of controlled correspondence and who may submit them.

OGD Provides Updates at the GPhA Fall Tech Meeting

Dr. Kathleen Uhl (Cook), Director Office of Generic Drugs (OGD), provided an excellent update on OGD’s progress under GDUFA. There were a number of interesting charts that described approvals, receipts and actions that defined what Cook called the “In Box” (what’s coming into OGD) and “Out Box” (productivity or what is going out of OGD).

Another 70 Month for ANDA Approval Actions

The Office of Generic Drugs (OGD) is starting off FY 2016 at the same level that they ended FY 2015, with a total of 70 approval actions, one less than September’s record total.  The breakdown is- 49 full approvals and 21 tentative approvals (TA).

While I am certain that industry would like to see more full approvals,

The Ying and Yang – CRLs vs IRs ECDs and Approvals

Complete Response Letters (CRLs) (remember those letters where FDA was going to respond all at once with Division level review and you were not going to get any more discipline specific letters?) are a harbinger of “approval issues that are too great to resolve through other means”. Yes, that’s right, expect a CRL if issues are complex or too vexing to permit approval.

No More FPL Required for ANDA Approval

In a Federal Register (FR) Notice today (here) , FDA has indicated that a long-held practice of requiring the submission of actual or printers proof of final printed labeling (FPL) will no longer be required for ANDA approval, and that OGD will accept draft labeling for approval purposes.

Annual Report of 505(q) Petitions and Impact on the Delay of Associated Applications


The FDA is required to produce a yearly report that addresses the number of petitions filed during the previous year, the number of those petitions that were designated as 505(q) petitions, and the number of the 505(q) petitions that delayed whether a 505(b)(2) application, ANDA or biosimilar approval.

The FDA report (here) indicates that,