The Office of Generic Drugs (OGD) reported some of its official statistics for August today. As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]
Although we were caught off guard by a slightly early update to the July metrics which preceded Official August approval and receipt numbers, we are happy to present them to you at this time. OGD issued 4 refuse-to-receive (RTR) actions and all four were for standard ANDAs. The Agency acknowledged (filed or received, whatever you […]
According to the unofficial August numbers derived from the FDA’s All Approvals list (here), the Office of Generic Drugs issued 58 full approval (AP) actions and 10 tentative approval (TA) actions during the month of August 2020. The number of APs and TAs are both the lowest number of approval actions in the past 7 […]
The Office of Generic Drugs released nineteen new and ten revised bioequivalence recommendations today. The Federal Register Notice (here) lists two tables with the new and revised recommendations as presented below: There are always concerns, when an existing guidance is revised, as to how it might impact […]
With six (6) reporting days left in the month, the FDA’s All Approvals List (here) has identified 43 full ANDA approval actions and 10 tentative approval actions. While this represents a bit slower pace for approval actions, there is still time to meet FY 2020 monthly averages by the end of the month. We want […]
OGD reported 69 full approval actions, which we hit on the head, (three of the full approvals were for first time generic approvals) and 13 tentative approval actions (we reported only 9, as that was all that was found on the FDA’s All Approvals site at the time) for a total of 82 approval actions […]
FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018. The FR Notice announcing the availability of the guidance (here) indicates […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
With ANDA approval, one would expect that market entry would soon follow application approval, right? Wrong! The data suggests that only about 40% of generic drugs approved in any year are actually launched in that year and, after 5 years, there are still about 30% of those products that have still not launched. While this […]
A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.” Basically, the press release goes on to describe fraudulent activities relative to the […]
