News Briefs
Community speakers bureau launched
First Clinical Research of Palo Alto, CA, a provider of clinical research best practices information, consulting, and training services, has launched a community outreach speakers bureau for the purpose of promoting clinical research to the public.
The bureau provides an international capability to tell the industry's story face-to-face at the thousands of schools, community centers, churches, and other places where people gather.
Within four days of sending out an e-mail announcement, the speakers bureau had signed up 170 speakers from 34 states and seven other countries. Now there are more than 200 speakers enrolled, Goldfarb says. The speakers include study coordinators, clinical research associates, administrators, university professors, and company presidents. However, many more speakers are needed for the bureau to have full geographic coverage, he adds.
The speaker's bureau web site has resources available for speakers, including slides, handouts, and public speaking tips in both Spanish and English. To learn more about the speaker's bureau or to volunteer to be a speaker, visit the web site at www.firstclinical.com/resources/bureau/bureau.html or www.firstclinical.com.
FDA warns against use of unapproved drug products
The FDA is cracking down on unapproved drugs, which the agency says are surprisingly prevalent. To address the issue, the agency has issued a new guidance: "Marketed Unapproved Drugs — Compliance Policy Guide."
Its estimates point to several hundred different unapproved active ingredients in prescription drugs on the market, which represent less than 2% of prescribed drugs. Such products have bypassed standard approval rules primarily because they were developed and marketed before successive changes to the drug approval process that is established in the Federal Food, Drug, and Cosmetic Act.
Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said that the newly issued guidelines are meant to encourage companies marketing such products "to comply with the drug approval process and ensure the safety and efficacy of their marketed products."
Enforcement priorities will be given to unapproved drugs that pose safety risks, lack efficacy and constitute health fraud. Manufacturers that do not comply with drug approval requirements could be subject to enforcement action.
Community speakers bureau launched; FDA warns against use of unapproved drug productsSubscribe Now for Access
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