Draft FDA Guidance for COCCIDIOIDOMYCOSIS

David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”.  He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS

QIDP Drugs – 4th Edition

>>> For the latest QIDP list, please click HERE  <<< Since our last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table which includes compound, sponsor and development stage (Phase). It also indicates whether a drug has been the topic of a Continue reading QIDP Drugs – 4th Edition

Antibiotics with QIDP Designation – – – Updated 9-30-14

For the latest QIDP listing, please click HERE   Since FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’.  Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside. While an official FDA list of drugs that have Continue reading Antibiotics with QIDP Designation – – – Updated 9-30-14