James G. Dickinson

Most Recent Articles by James G. Dickinson

Industry-sponsored trials reach record high in '07

The number of new industry-sponsored clinical trial starts went up 12% to a record high in 2007, according to data released by Parexel International Corp.

FDA doesn't approve most generics reviewed in first cycle

An HHS Office of Inspector General report says the FDA does not approve 96% of new generic drugs reviewed during their first cycle because they contain chemistry deficiencies.

DDMAC responds to queries

DDMAC responses to queries posed by drug sponsors or manufacturers regarding ad/promo issues may only be regarded as official (for legal purposes) if they are received in letter form, the division's director, Thomas Abrams says.

Court limits False Claims Act liability for whistleblowers

In a ruling that provided comfort to drug companies defending dissident former employees' whistleblower suits, the US Supreme Court said in June that False Claims Act liability is limited to acts done with an intent that the government itself pay a false claim.

Amid high praise, FDA's top cop quits

Calling it "a tremendous loss for the agency," FDA commissioner Andrew von Eschenbach announced in June that the impending departure after three years in the job of the agency's top enforcement officer.

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