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Mass. medical industries, FDA to talk regulations

By The Associated Press
July 11, 2011

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BOSTON—The state's biotechnology and medical device companies are set to meet with the Federal Drug Administration Commissioner to discuss industry guidelines, regulations, and the agency's relationship with the companies.

Massachusetts Sen. John Kerry, who is hosting Monday's roundtable talks, says the FDA is considering many policy changes affecting industries' jobs and medical innovations.

Companies from the Massachusetts Medical Device Industry Council and Massachusetts Biotechnology Council plan to discuss possible changes to the approval process of medical devices and user fees, and best practices for drug development with Commissioner Margaret Hamburg.

Kerry says he hopes these talks build a collaborative, open relationship between the companies and their regulator.

Biotechnology companies met last month at the BIO International Convention to discuss similar issues.

Boston is scheduled to host the convention next year.