We have heard a lot about the use of real world evidence (RWE) and real world data (RWD) lately in the context of potential approval of new uses of approved drugs. Well, on July 16, 2021, FDA “approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of […]
Dr. Janet Woodcock, the Acting FDA commissioner, is a long-time career executive having begun her tenure in 1986. Full disclosure, I worked with or for her when I was at the Office of Generic Drugs from 1985 through December 1995 in various capacities. She has been serving as Acting Commissioner since her appointment for over […]
Three FDA Advisory Committee members resigned over the FDA’s decision to grant accelerated approval to aducanumab for treating Alzheimer’s Disease. One member said, when he resigned, that “this is the worst decision the FDA has ever made.” I get it. When the entire committee voted against approval (full approval), the FDA kind of backdoored its […]
For the last 5 or so years, the FDA has told applicants that they could likely submit an ANDA for a synthetic peptide product (40 amino acid chains or fewer) when the reference listed drug (RLD) was of rDNA origin but the guidance on which products, how, and what would be required was often sketchy. […]
Covering a multitude of subjects, the Agency published eight new guidance documents ranging from the ICH M9 BCS classification system to a Q&A document on qualified infectious disease designations. Here is a list of the eight guidance documents. M9 Biopharmaceutics Classification System-Based Biowaivers (here) E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis […]
The Office of Generic Drugs (OGD) provided the final set of metrics to complete the March 2021. While many of the numbers are consistent with other months of this FY, there are a couple of surprise figures which we will cover, and will provide our commentary in an effort to try to explain them. There […]
Just nine (9) days ago, I posted a blog and article (here) on the issue of paper prescribing information – package inserts! The overall takeaway was that FDA is ready to move on this issue. There was a proposed rule sitting dormant, because every year since its proposal, e Congress has included a provision in […]
While there still may be a few more stragglers that have not yet hit the FDA’s “All Approvals List” as of May 6, 2021 (here), we will catch them when the OGD releases its official numbers for April sometime in the next two weeks. The total for full- and tentative-approval actions reported was 71 which, if […]
An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry. Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]
Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)). Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]
