FDA revises guidance on work with spore-producing organisms for biologics
WASHINGTON The Food and Drug Administration has issued new guidance telling biological drug manufacturers that spore-bearing organisms used to make vaccines and other products may now be worked on in a contained portion of a larger plant.
Due to the hazards that some spores pose, the old guideline read that “all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building or in a completely walled-off portion of a multi-product building,” with entrances separate from the rest of the plant. The FDA no longer requires the use of specifically dedicated buildings for this work.
Since 2004, the FDA has been issuing guidelines to allow for more flexibility for drug manufacturers.
GSK will supply over 30 million doses of flu vaccines to U.S. this season
PHILADELPHIA The influenza virus vaccines Fluarix and FluLaval from GlaxoSmithKline will have a combined total of 30 million to 35 million doses supplied to the U.S. markets for the 2007-08 influenza season.
The vaccines will be delivered in phased approach for the rest of September and all of October with completion occurring at the end of October. “Providing an ample and steadily growing supply of flu vaccine has been a priority for GlaxoSmithKline since entering the U.S. market in 2004,” said David Pernock, senior vice president of GSK. “Over the years, GSK has significantly increased its influenza vaccine manufacturing capacity, and we have taken steps to improve the way this product is distributed to those who need it.”
Last year, the company sent about 25 million doses of the drugs for flu season.
NACDS pledges to award at least $100,000 in scholarships
ALEXANDRIA, Va. The National Association of Chain Drug Stores Foundation is pledging to award at least $100,000 this year in scholarships, and has begun accepting applications.
Last year, 40 students were awarded a scholarship, an increase of three from 2005, and this year it looks like the foundation wants to add award the scholarship of $2,000 to at least 50 students. Also, some select recipients will receive named scholarships in the amount of $2,500, in addition to the $2,000 scholarship.
Applicants must be at least in their second year of pharmacy school, as well as have experience and the desire to work in a chain community pharmacy.
“The NACDS Foundation is continuously committed to advancing the pharmacy industry for the good of the public. An important part of our industry is its future, and that is what these students represent,” said Phil Schneider, NACDS Foundation president. The deadline for all applications is Oct. 19.