The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the Generation and use of Health-Based Exposure Limits” held on 20-21st June 2017 at the European Medicines Agency.
The first Activities Report of the Generic Drug Program FY 2018 (here) issued today and it is a record breaker for approvals and Complete Response Letters (CRL).
FDA broke the 100 mark with 101 approval actions with 87 full approvals (AP) and 14 tentative approvals (TA) (we predicted about 84 APs and 13 TAs back on November 2nd (here ).
As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR). The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results.
From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations.
It is certain that FDA is continuing to apply pressure on this industry with no letup in sight.
The Path to Bioequivalence – Great Progress – Great Opportunities, was presented by Charlie DiLiberti, President, Montclair Bioequivalence Services LLC, at this week’s Association for Accessible Medicines (AAM) meeting. Charlie pointed out the great progress FDA has made in developing new bioequivalence techniques or alternate methods through the GDUFA regulatory science initiative. He pointed to the many new BE guidance recommendations,
Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA. It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda,
I was lucky enough to moderate the panel on the Priority and Expedited Review with panel members Scott Tomsky and Kurt Karst at the Association for Accessible Medicines (AAM) on November 8, 2017. You all know them and it was interesting that the three of us were, without a doubt, on the same page.
What do I mean?
Lots of topics have been discussed on the first two days of the Association for Accessible Medicines (AAM) Fall Technical Conference. Many of the detailed presentation and speakers’ comments had what I refer to as hidden gems that might have escaped full view. Here are some of the noteworthy tidbits:
- What about those ANDAs that have had complete responses?
Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right. At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter,
My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network. Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends,
If you have been reading my blog regularly, I guess I have gotten much of the reading of the wind correct because there was not a lot of new information in Cook’s (Kathleen Uhl M.D., Director, Office of Generic Drugs) talk at this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD.
The FDA today posted a revised draft guidance (here) on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II. We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong.
Many in the industry have complained that with the stated purpose of the PFC to identify all facilities used in the proposed application the Agency could determine whether a facility inspection was needed.
While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement. It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs. These numbers may go up a bit if some stragglers show up when the numbers are scrubbed for the official totals.
Well after the first 5 years of GDUFA I, we now have a comparative look at all 5 years for various metrics reported by the FDA in their Activities Report of the Generic Drug Program. In the chart below the 5- year highs are bolded and some trends can be seen. For instance, the number of post CRL meetings was highest in year two of the GDUFA program.
Remember certain GDUFA fees were assessed on October 1, 2017 including the new FDA program fee and establishment fees. The FDA published arrears lists today and there are a lot of folks on those lists. If there is an error or if you need to pay the fee you should either rectify the situation quickly or pay the owed fee.