James G. Dickinson

Most Recent Articles by James G. Dickinson

Industry-sponsored trials reach record high in '07

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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

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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

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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

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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

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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.

More Articles by James G. Dickinson

Opinion

How to Shatter the Glass Ceiling

How Pharma Can Benefit from the Transformation of Pharmacy

Newsletters

Live at MM&M Transforming Healthcare

Pharma faces its 'oh, shit' moment

In his keynote address at the MM&M Transforming Healthcare conference, Dr. Gautam Gulati says the industry is being outpaced by its innovation.

Merck, Takeda execs: Is AI the new bad app?

One executive referred to AI as a "black box" and as the "Tower of Babel."

Value-based care requires innovators to challenge the status quo

Execs stressed the importance of collaboration, consumer-mindedness.

Admetsys wins the 2017 MM&M Startup Showdown

The artificial pancreas can provide value to the health system.

Top 40 Healthcare Transformers

MM&M honors 40 upstarts and veteran innovation gurus.

Top 10 Innovation Catalysts

For the first time MM&M honors a group of 10 agency execs.