All submissions to CDER to be electronically submitted on common form by 2008
WASHINGTON Beginning in January 2008, all electronic submissions to the Center for Drug Evaluation and Research must use the electronic common technical document format, according to bio-itworld.com
This applies to new drug applications, biologics license applications and investigational new drug applications.
Through its structure, the eCTD enables the creation, review, lifecycle management and archiving of electronic submissions and meets a list of criteria that make submissions technically valid.
Virginia Ventura, regulatory information specialist in CDER’s Office of Business Process Support, sees the eCTD as a major step forward. “The eCTD is paperless and establishes a single application format for all applications, is consistent with International Conference on Harmonisation guidelines, and avoids duplicative internal processes,” she explains.
Pharma, biotech companies in line of wildfires
SAN DIEGO With the wildfires still blazing in areas across San Diego, such pharma and biotech companies as Pfizer are preparing for closures and even evacuations of some of their facilities, according to drugresearcher.com.
Pfizer’s La Jolla research and development site is a 33.5-acre campus, with facilities covering more than 1 million square feet, including Pfizer’s vaccines research and The Pfizer Incubator, a new facility where the company is financing life science start-ups. The HIV drug Viracept is produced at the site, as well as new treatments for cancer and diseases of the eye.
Across San Diego County, there are more than 500 life science companies employing more than 36,000 people, according to industry association Biocom. The companies range from small biotechs to some of the biggest names in drug development, such as Johnson & Johnson, Bristol-Myers Squibb, Amgen, Biogen Idec, Genentech and Pfizer. Between them, they generate more than $23 million for the economy every day.
Pharmacy OneSource ranks in Deloitte’s top 100
BELLEVUE, Wash. Pharmacy OneSource has been ranked number 84 on Deloitte’s Technology Fast 500, a ranking of the 500 fastest growing technology, media, telecommunications and life sciences companies in North America. The company grew 2011 percent in fiscal revenue from 2002-2006, which was the time period used to measure each company’s ranking.
“We enjoy our strong relationship with pharmacy professionals and the opportunity it brings to stay intimate with their needs,” said Keith Streckenbach, chief strategy officer. “This knowledge, combined with excellent hires, has catalyzed our growth.”
Pharmacy OneSource was also ranked sixth on the Washington State Technology Fast 50, which ranks the 50 fastest growing technology firms in Washington State.