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The comprehensive drug safety bill introduced in the Senate last week would require all sponsors of clinical trials in the country to participate in a central NIH registry, including reporting their results.
The Senate’s approval of an amendment allowing for the importation of drugs from Canada undermines both government border control and the safety and efficacy of the U.S. drug supply, an industry group says.
A bill introduced June 21 by bipartisan group of U.S. senators seeking to improve the safety of OTC drugs and dietary supplements could see its first legislative action as early as next week.
The FDA needs more money to be able to meet the demand for improved post-market studies of drug safety and accelerated approval of new brand and generic drugs, a key agency official said, May 16.
The FDA opposes lawmakers’ efforts to limit the agency’s ability to grant conflict-of-interest waivers for advisory committee members, arguing that such a move would undermine its ability to have the necessary expert advice needed to make drug policy, an agency official says.
Smaller public companies — including many biotechnology firms — face disproportionately higher costs as a percentage of revenue to meet the internal control requirements of Sarbanes-Oxley (SOX) than do their larger counterparts, according to a study by the Government Accountability Office (GAO).
The pharmaceutical industry is trying to persuade states not to pass equivalent versions of the federal False Claims Act (FCA),
arguing that such laws are unnecessary and could end up doing more harm than good, industry attorneys say.
The fact that an SEC advisory committee has overwhelmingly recommended that the agency grant relief from Sarbanes-Oxley (SOX) reporting and auditing requirements for small companies may not have the influence on the SEC that the pharmaceutical and biotechnology industries may believe, an agency spokesman says.
A Government Accountability Office (GAO) report on shortfalls in the FDA’s drug review protocols did not go far enough in recommending changes, but it still may provide the momentum for dormant legislative reforms to become law, sources say.
There are many steps the U.S. needs to take to improve its healthcare system, including a greater dedication to innovation and tort reform, J.P. Garnier, CEO of GlaxoSmithKline says.