Executive Summary US FDA’s drug center has been hiring more employees than it has lost over the last few months and hopes the Office of New Drugs reorganization will help retention. The US FDA’s new hiring programs are beginning to pay dividends, as incoming employees are outnumbering departures within the Center for Drug Evaluation…
Executive Summary Three center directors agree that Gottlieb’s facility for public communications is a boon for FDA – and that the commissioner is appropriately hands-off when it comes to day-to-day decisions on scientific or policy issues. US FDA Commissioner Scott Gottlieb has been getting generally high marks from the agency’s external stakeholders, and it…
Executive Summary CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try. Asked about the US’s Right to Try law, Center for Biologics Evaluation and Research Director Peter Marks said he needed to “carefully side-step” the issue, but he was willing to…
Executive Summary Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government. The US FDA’s Center for Drug Evaluation…
FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved for use with an entire class of drugs, FDA Commissioner Scott Gottlieb told BioCentury. Class-wide labeling would give physicians more flexibility to prescribe drugs and reduce the likelihood of patients having to undergo multiple biopsies to…
Executive Summary CBER Director Peter Marks says the “half-life” for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery. Genetic Medicine with dna isolated on white.3d rendering Gene therapy sponsors should not expect the US FDA’s latest guidances to maintain a long useful life.…
When President Donald Trump rolled out an ambitious pilot program to lower the costs of physician-administered drugs in late October, policy experts expected the same swift condemnation Congress and the health care industry directed at former President Barack Obama’s Part B demonstration plan. But so far, at least, the outrage hasn’t been nearly as loud.…
In an effort to determine best practices and ensure consistent clinical interpretation of tumor mutational burden ( TMB) assessment for cancer patients, a group of diagnostic test partners conducted an in silico analysis and found that panel-derived TMB strongly correlated with whole-exome sequencing (WES) data provided from The Cancer Genome Atlas (TCGA). The group’s findings…
In a group of sponsored presentations at last week’s annual meeting of the Association for Molecular Pathology, Thermo Fisher Scientific product users reported on their experiences in a variety of clinical areas, including liquid biopsy, immuno-oncology, and pharmacogenomics. According to Anagh Vora, head of medical affairs for clinical NGS and oncology at Thermo Fisher…
I am a big proponent of clinical trials. I think everyone should have access to them and any trial that they qualify for should be offered – regardless of whether or not I think they are “appropriate” (however one chooses to define it). It’s not only good medicine, but now some data from SWOG shows…
