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, they […]
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.
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.
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).
I just received an update for the October approval numbers from OGD and the full approvals have been revised upward from 49 to 51.
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 […]
Lachman Consultants recently exhibited at BioProcess International Conference and Exposition at the Hynes Convention Center, Boston, MA.
With Warning Letters (WLs) and significant FDA 483 observations continuing to confront the compounding pharmacy space, FDA is entering into rounds two and three of inspections to determine if corrective actions have been adequately and timely completed and if the compounding pharmacies understand compliance in this space
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To Compound or Not to Compound? That is the Question! FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use […]
