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The FDA's Office of Combination Products met the time requirement for assigning combination products to agency centers in 100 percent of the requests it received over a seven-month period, the office said in its first annual report to Congress released Feb 27.
The FDA concluded its inspection of Utah Medical Products (UTMD) on March 3 by issuing the company a Form 483 citing seven violations of the agency’s quality system regulation (QSR).
The FDA on March 4 approved Boston Scientific’s Taxus Express2 paclitaxel-eluting coronary stent system for the U.S. market, adding a fierce challenger to the highly competitive coronary stent field.
The FDA cannot accept Minnesota Gov. Tim Pawlenty’s invitation to inspect the operation of its drug reimportation website, according to a high-ranking agency official. “The FDA does not have the legal authority to engage in the sort of test program that Gov. Pawlenty is proposing,” William Hubbard, the FDA’s associate commissioner for policy and planning, told WDL last week.
The Senate Finance Committee is scheduled to hold a hearing today on the nomination of FDA Commissioner Mark McClellan to head the Centers for Medicare & Medicaid Services, under an agreement reached last week by Committee Chairman Chuck Grassley (R-Iowa) and ranking committee Democrat Sen. Max Baucus (D-Mont.).
To help generic drug manufacturers determine if they are eligible for marketing exclusivity, the FDA will soon list on its website the date it receives the first substantially complete new drug application challenging a patent on a brand drug.
The new Medicare prescription drug law contains government regulations and private market incentives that could boost generic drug Rx volumes by another 15 percent, according to federal officials and private-sector healthcare executives.
Three foreign websites were shut down recently by the FDA for selling counterfeit contraceptive patches that contained no active ingredients and do not protect against pregnancy.
The voluntary (FDA 3500) and mandatory (FDA 3500A) MedWatch reporting forms have been revised by the FDA to better capture adverse events involving reprocessed single-use devices (SUDs).
The Center for Devices and Radiological Health (CDRH) wants premarket approval (PMA) applications to contain statistics in the manufacturing section that support the number of process validation runs done on devices to prove that the number was appropriate, according to an official from the center.