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The NIH needs to better monitor outside work by its scientists to prevent questionable arrangements such as the secret consulting between NIH scientists and drug companies uncovered last year, according to a report by HHS Inspector General Daniel Levinson.
Less than one week after it passed both the House and the Senate, President Bush signed the Medical Device User Fee Stabilization Act of 2005 (MDUFSA) into law.
Following approval in the House and unanimous approval in the Senate, the Medical Device User Fee and Stabilization Act (MDUFSA) was passed by Congress last week in a move to help smaller medical device companies better afford the costs associated with submitting new medical devices for FDA review and approval.
PhRMA has launched a new online clearinghouse that it calls the first website to collect and archive reports, articles, warning letters and policy papers on drug importation.
Medical technology association AdvaMed recently called upon Congress to create financial incentives and establish a safe harbor provision to help kick-start a health information technology (HIT) initiative it says will "revolutionize the healthcare delivery system."
A bipartisan majority of House lawmakers has asked the Republican leadership to schedule a full floor vote on drug importation before the current Congressional session ends.
The pharmaceutical industry would receive tax incentives and intellectual property protections for developing bioterror antidotes under new biodefense legislation introduced in the Senate.
Lester Crawford, the Bush administration’s nominee to become the next FDA commissioner, said he doesn’t believe the agency’s gold standard image has been damaged by recent drug-safety concerns, but he acknowledged that safety is an area where the FDA’s reputation is vulnerable.
Lester Crawford, the nominee to become the next FDA commissioner, said he doesn’t believe the agency’s gold standard image has been tarnished by recent drug-safety concerns, but he acknowledged that safety is an area where the FDA’s reputation is vulnerable.