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The Bush administration's nomination of Andrew von Eschenbach to be the FDA commissioner faces an uncertain future that has less to do with the new Democratic Senate leadership than it does with members of the president's own party.
CDRH should add new "cross-cutting collaborative product groups" to its structure to help it deal with the total product life cycles of the devices it regulates, says an agency advisory team.
International Brachytherapy (IBt) violated enough current good manufacturing practices (cGMPs) that the FDA may prohibit the firm from shipping its devices into the U.S. until the problems are fixed, the agency said in a warning letter.
The device industry is engaged in closed-door talks with the FDA over its user-fee program, in which firms pay the agency when they submit their applications for product approvals.
With the Democrats taking control of the House of Representatives for the first time since 1994, the healthcare agenda will now be in the hands of some very vocal critics of HHS policy, FDA oversight and prices, particularly in Medicare.
Orthopedic devicemaker Endotec said it will challenge an FDA complaint in court and argue that the agency lacked adequate information when it sought a permanent injunction against the company.
Federal funding totaling $3.8 million will support the use of laser opto-acoustic imaging technology developed by Fairway Medical Technologies for Phase II breast and prostate cancer detection research, the firm announced Nov. 7.
The use of genetic testing to develop personalized dosing for medicines can save lives and potentially billions of dollars, a group of FDA officials says.
Forty-three women have filed suit against Ortho-McNeil Pharmaceutical and McKesson alleging the companies misrepresented the known risks associated with the use of Ortho Evra, a birth control skin patch.
Investors should sell their shares of Mentor "ahead of and after the upcoming silicone gel breast implant approval," Lazard Capital Markets analyst Alexander Arrow said in a Nov. 7 research note.