Jesse Goodman
Jesse Goodman
approval delivery immune option patients product provides treatment unique
This is an important approval for patients who need lifesaving immune globulin products. This new product provides a unique new treatment delivery option to patients and their physicians.
pass produced safety tests vaccine
In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S.,
kinds simpler tests
The simpler kinds of tests for antibodies won't work,
area promising research
That's been an area of a lot of research, ... promising technologies.
actions additional amount determine evaluate fda flu market needed supply vaccine work
Additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward.
actual additional although assessment available beyond bottom certainly encouraged fda hopeful last license line next number positive premature reached recent respect supply terms track vaccine year
It's premature to put a number on the actual supply for next year because manufacturing is continuing, and there are still some uncertainties with respect to Chiron, but we are very encouraged by being able to license this new vaccine, and also I think Chiron has reached a significant milestone in terms of their recent FDA inspection. We're encouraged by the positive track they're on, although the assessment is ongoing. The bottom line is it's encouraging. We certainly are hopeful that there will be additional vaccine beyond what was available last year.
actions additional amount determine evaluate fda flu letter market needed pass positive produced progress safety shows supply tests vaccine week work
The letter that we issued to them this week is a positive development and shows significant progress on their part. However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward. In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S.
awareness benefits broad hiv home increase input people potential public seeking simple test testing
We are enthusiastic about the potential of having a very accurate, simple test in the home to increase testing and awareness in people about their HIV status. But we are seeking broad input from our panel and the public on the benefits and any risks.
alert banks blood weeks
Two weeks ago we issued an alert to blood banks
achievement banks blood develop health licensed organ patient public quickly remarkable screen test throughout tissue
To develop an investigational test to screen blood, tissue and organ donors, and to get this test in blood banks throughout the country, and then licensed this quickly is a remarkable achievement for public health and patient safety.
address facility flu issues liverpool pleased prepare steps taken
We are pleased that the Chiron Corp. has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season,