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DC battle erupts over off-lable reprints

An FDA plan to allow drug companies to distribute reprints of journal articles dealing with off-label drug uses has run into fire from Sen. Charles Grassley (R-IA), Public Citizen and two university...

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Woodcock takes GMO to the next level

The FDA's director of drugs, Janet Woodcock, is pushing her manufacturing and product quality experts to "reinvigorate" her brainchild "GMPs (Good Manufacturing Practices) for 21st Century" initiative...

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FDA's 'Sentinental Initiative' to improve product safety

The FDA says it is undertaking a new initiative to develop a system to query a broad range of databases to identify possible post-marketing adverse events.

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Kweder: new law slows down FDA approvals

While it holds exciting promise for protecting public health, last year's FDA Amendments Act (FDAAA) is actually slowing down new drug approvals, a key agency official warned in June.

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Drug company outsource probe sought

Sen. Sherrod Brown (D-OH) wants the FDA to evaluate how it protects the American public from drug products containing tainted, outsourced ingredients.

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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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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...

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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...

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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.

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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.

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DC battle erupts over off-lable reprints

An FDA plan to allow drug companies to distribute reprints of journal articles dealing with off-label drug uses has run into fire from Sen. Charles Grassley (R-IA), Public Citizen and two university...

View Article

Woodcock takes GMO to the next level

The FDA's director of drugs, Janet Woodcock, is pushing her manufacturing and product quality experts to "reinvigorate" her brainchild "GMPs (Good Manufacturing Practices) for 21st Century" initiative...

View Article

FDA's 'Sentinental Initiative' to improve product safety

The FDA says it is undertaking a new initiative to develop a system to query a broad range of databases to identify possible post-marketing adverse events.

View Article


Kweder: new law slows down FDA approvals

While it holds exciting promise for protecting public health, last year's FDA Amendments Act (FDAAA) is actually slowing down new drug approvals, a key agency official warned in June.

View Article

Drug company outsource probe sought

Sen. Sherrod Brown (D-OH) wants the FDA to evaluate how it protects the American public from drug products containing tainted, outsourced ingredients.

View Article


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.

View Article

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...

View Article


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...

View Article

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.

View Article

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.

View Article
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