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.

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 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.

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.

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.

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

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.

As a new study finds that pharma has become Washington's largest lobby in terms of dollars spent in campaign contributions, a high-stakes battle is looming in the heat of election season over what those dollars can buy—defeat of new advertising curbs, blockage of drug imports from Canada and Mexico, stronger patent protections and more.

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.

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 and move it to the next level.