The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here). The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States. The guidance clearly identifies the added revisions, […]
According to the FDA all Approvals list (here), approvals for February 2018 did inch up a bit to 29 full approvals and 4 tentative approvals, but they are still far below the OGD norm. We had previously predicted that it would take about 3 months before the approval train got back on track, and now […]
The FDA has issued a guidance (here) that provides clarification on the definitions of suspect and illegitimate products under the Drug Supply Chain Security Act (DSCSA). The definitions are designed to help those in the supply chain better and more accurately characterize problem products they may uncover. The guidance provides the following definitions: SUSPECT PRODUCT—The […]
Getting back to the elemental impurities (EI) issue, we received additional interesting feedback from one ANDA sponsor. They said sometimes “this stuff gets tricky.” The sponsor related a situation of a capsule ANDA product that could be administered multiple times a day at high maximum daily dose. The empty capsule shell had the standard limit […]
As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A […]
After my post on Thursday (here) regarding the slowdown in ANDA approvals because of lack of documentation of elemental impurities, and my assumption relative to NDA applicants, I received some interesting feedback from two NDA applicants. I was told that the New Drug Division would not hold up issuing an approval action letter if the […]
The new warnings which FDA says will be incorporated into both clarithromycin’s brand (Biaxin) and generics labeling come after review of a number of long-term studies revealed an increased risk of death in patients with preexisting coronary disease. The interesting finding is that the risk is not necessarily immediate, but can occur in patients with […]
As of this morning, there were only 20 full ANDA approvals and 2 tentative approvals listed on FDA All Approvals list (here). In contrast, there were 9 NDAs with full approvals and one tentative approval. Looks like ANDAs have been more impacted by the elemental impurities (EI) documentation requirement than it has for NDAs. I […]
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) at the AAM Annual Meeting today, gave some hope to generic applicants regarding the way agency assessments will be conducted in the not too distant future. The goal is to improve the efficiency and effectiveness of the review process. Why is this necessary? Dr. […]
There is a proposed change to 180-day exclusivity which is awarded to the first -to-file (FTF) applicant with a paragraph IV certification. The proposal would trigger the 180-day exclusivity period if a subsequent applicant obtains tentative approval prior to the FTF applicant gaining final approval. While this on its face may in some instances appear […]
