James G. Dickinson

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

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

"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.

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.

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.

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

Anti-corporation protests on Wall Street and beyond send a message that pharmaceutical marketers and regulators alike should ponder.

Working with the private-public Biomarkers Consortium at the Foundation for the National Institutes of Health, FDA is looking at options to ease the development path for antibiotics.

Briefs filed in recent off-label marketing cases continue the confusion that exists in defining acceptable practices for drug and medical device companies.

Sen. Charles Grassley (R-IA) is criticizing Office of Management and Budget (OMB) officials for weakening an HHS transparency rule on disclosure of financial ties between medical researchers and the drug industry.