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Washington Insider Articles

As I See It: Political interference in FDA

James G. Dickinson February 01, 2012

Political interference in FDA's scientific decisions is growing, well-hidden phenomenon

Republican's bill to reform FDA, save jobs

James G. Dickinson February 01, 2012

Sen. Dan Coats (R-IN) has introduced a bill to clarify and reform FDA's mission in order to keep jobs from going overseas.

New drug sponsors cause FDA chaos

James G. Dickinson February 01, 2012

"Emerging sponsors" or companies that have never had an approved application to market a drug are wreaking havoc on review activities at FDA's drugs center, says Office of New Drugs director John Jenkins.

As I See it: Conflict-of-interest rules

Paul D. Thacker January 01, 2012

Watching pharma executives, sometimes you have to wonder, "Will these guys ever learn?" Case in point, industry's assault on the FDA's conflict-of-interest rules.

New approval paths are needed, says Woodcock

James G. Dickinson January 01, 2012

FDA director of drugs Janet Woodcock says she is so optimistic that biomedical science and the war on cancer will produce "startlingly better" therapies that the research community should develop new approval paths.

Extend brand exclusivity: researchers

January 01, 2012

Researchers are urging Congress to extend the exclusivity period for branded drugs by seven years and remove the initial 180-day marketing exclusivity granted to first-to-file generics.

As I See It: Risk management

December 01, 2011

Risk management means more than REMS strategies and tactics, or validated methodologies and therapeutic registries. What it's really about is assuming the mantle of responsibility.

Senators try to clear path for new antibiotics

James G. Dickinson December 01, 2011

Sens. Richard Blumenthal and Bob Corker introduce the Generating Antibiotic Initiatives Now (GAIN) Act to spur antibiotic development to fight the spread of antibiotic-resistant bacteria.

Woodcock: More tech, less scrutiny

James G. Dickinson December 01, 2011

FDA drugs director Janet Woodcock says the next 25 years could bring advances with the potential to make drug development more reliable—and decrease regulatory oversight