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Rep. Rosa DeLauro (D-Conn.), a frequent critic of the FDA's drug safety system, has seized on a recent agency report as evidence that the agency's postmarketing efforts are failing, but industry and activists are skeptical of her reasoning.
The FDA warned Stem Cell Pharma for implanting stem cells in test subjects without following any standard operating procedures (SOPs) and without an approved license.
Keeping up with state drug marketing laws will be a challenge for companies but should get easier with time as the laws become more uniform, industry experts said at an FDAnews audioconference.
While the climate for drug safety reforms was thought to have improved with Democrats' takeover of both chambers of Congress, the obstacles remain the same for drug safety legislation recently introduced by Sens. Chris Dodd (D-Conn.) and Chuck Grassley (R-Iowa), sources say.
Barr Pharmaceuticals and its subsidiary Pliva have won final FDA approval to manufacture and market injectable azithromycin, a generic version of Pfizer's Zithromax.
Strong pharmaceutical sales helped Johnson & Johnson (J&J) reach a 3.5 percent increase in fourth quarter earnings, even after the major cost of acquiring Pfizer Consumer Healthcare, the company announced.
The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued late Tuesday.