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.

The worst fears of the drug industry—that state attorneys general (AGs) will add their muscle to the FDA's in marketing enforcement—may be seen in Merck's recent $58 million settlement of state consumer fraud claims arising from the marketing of since-withdrawn Vioxx.

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 professors even as an industry coalition began efforts in April to have the FDA loosen its proposal.

The FDA has a stale and outdated regulatory system for overseeing clinical trial compliance, but several initiatives are under way to modernize it, according to Division of Scientific Investigations director Leslie Ball.

FDA commissioner Andrew von Eschenbach was directed to "stop the buzzwords and toe-dancing" during intense, aggressive questioning by House Energy and Commerce chairman John D. Dingell (D-MI) at an acrimonious Oversight and Investigations Subcommittee hearing on the agency's inability to prevent the entry of contaminated products.

Three key leaders of the House Energy and Commerce Committee are circulating a discussion draft of their proposed Food and Drug Administration Globalization Act of 2008.

The worst idea on Capitol Hill right now involves giving the FDA control of tobacco.

Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) have introduced legislation that would create a regulatory pathway for the FDA to approve follow-on or generic biologics.

As DTC promoters push all kinds of genetic tests, a high-level HHS advisory committee is preparing to recommend that FDA should have some level of oversight for all lab tests, including the more than 1,100 genetic tests now offered by hundreds of labs across the nation.