Elite Pharmaceuticals Inc (ELTP)

[Gman24]

This new approach by the FDA can only benefit Elite with its SUPERIOR technology..


New Era from FDA?

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CAMBRIDGE — The head of the US agency that approves medicines Friday called for more regulatory flexibility and “a new era of partnership” with the biopharmaceutical industry in bringing new treatments to patients.

“We see this model emerging where we don’t just wait for an application to come to us,” Food and Drug Administration commissioner Margaret Hamburg told more than 300 drugmaking executives at the annual meeting of the Massachusetts Biotechnology Council trade group. “We engage with you early and work with you throughout the development process.”

Hamburg said the partnership promised “swifter, more efficient product development and product review” after years of criticism from industry that the drug approval process was too long and cumbersome. FDA officials last year added a “breakthrough therapy” designation to its arsenal of programs meant to accelerate the review of drugs that address pressing unmet medical needs and improve the communications between drug companies and regulators.

Together, the programs can help three to five years off the research and development cycle and months off approval times for new drugs, she said.

“We are working hard to find ways to decrease the time between discovery, research, and approval,” Hamburg told her audience at the Royal Sonesta Hotel. “It matters to all of you, but it especially matters to patients.”

US Senator Elizabeth Warren, Democrat of Massachusetts, who introduced Hamburg, repeated a call she made at a Greater Boston Chamber of Commerce forum last fall to double the National Institutes of Health budget, which basic funds scientific and biomedical research at Massachusetts teaching hospitals. Many state biotechnology companies piggyback on that research to develop therapies to treat a range of diseases and chronic conditions.

http://betaboston.com/news/2014/04/04/fda-chief-calls-for-a-new-era-of-partnership-with-biotech-firms-at-conference/