QIDP, a Liberal Hand-Out from FDA

On our blog site, ‘QIDP’ stands for “Qualified Infectious Diseases Product” but when you look up ‘QIDP’ on the internet, you will find that it also stands for “Qualified Intellectual Disabilities Professional”. Looking at the more recent crop of ID Continue reading QIDP, a Liberal Hand-Out from FDA

TXA-709 –  New Kid on the Block

When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is Continue reading TXA-709 –  New Kid on the Block

Aradigm Lost in ORBIT – Hayward, We Have a Problem

It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. When an antibiotic is not evaluated on the basis of its antimicrobial activity but on its ability to Continue reading Aradigm Lost in ORBIT – Hayward, We Have a Problem

Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

There is much interest in inhaled antibiotics these days.  Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy Continue reading Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

Prospecting for New Antibiotics

The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA expedited review and more.  In addition, FDA made it quite easy to garner the label.  Continue reading Prospecting for New Antibiotics