New drug approval reports seem to cast doubt on critics' charges that the FDA has raised the bar in obtaining drug approvals.

House Energy and Commerce Committee chairman John Dingell (D-MI) is circulating a revised draft of his proposed FDA Globalization Act, incorporating changes negotiated by committee staffers with the FDA and the drug industry since the original draft was released in April.

Sen. Sherrod Brown (D-OH) is renewing his probe into the effect of drug company outsourcing on drug safety by asking Merck to explain the safety implications of its outsourcing practices.

Last year's FDA Amendments Act will bring historic change to the agency and the industry, the likes of which has not been experienced for decades, according to the FDA director of new drugs, John Jenkins, MD.

Another bad idea from government policy wonks surfaced in July when an FDA enforcement director told the Wall Street Journal his agency is using press releases as a vehicle for serving notice on certain companies that they are out of compliance with regulations, and to get their acts together.

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.