Make that 72 ANDA Approval Actions
I just received an update for the October approval numbers from OGD and the full approvals have been revised upward from 49 to 51.
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 […]
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
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 […]
FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. This draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms
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.
Partial updates to the Generic Activity Report for FY 2015 were recently published and, while we see a recent surge of approvals, the number of Complete Response Letters (CRLs) issued appears to be flat across all of the first three GDUFA Cohort years.
The Office of Generic Drugs (OGD) is evolving as the GDUFA process is gaining steam, and the pieces are coming together regarding coordination of reviews, and as efficiency in the review and approval process improves. Here are some interesting facts that have come out of OGD
With October 1, 2015 signaling the start of cohort year 4 of the GDUFA program, the receipt and approval numbers are in the book for first three years of the program. Let’s take a look at the numbers to see where we may be heading.
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.