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The U.S. government may step in to regulate the use of doctors’ prescription data if states create a “bureaucratic headache” by imposing their own laws, according to one expert.
The U.S. government may step in to regulate the use of doctors’ prescription data if states create a “bureaucratic headache” by imposing their own laws, according to one expert.
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).
How the FDA defines a hospital for the purpose of its rule requiring bar codes on drug labels is a key question affecting health care providers and drug manufacturers’ ability to comply with the rule, a hospital official says.
New Hampshire is one step closer to being the first state to ban pharmaceutical companies from obtaining doctors’ prescription information for the purpose of boosting sales after a May 4 vote in the state Senate.
The United States Pharmacopeia (USP) has announced a public comment period through Aug. 15 for proposed changes to its rule setting practice standards that help ensure compounded sterile preparations (CSPs) of drugs are of the highest quality.
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.
The FDA has issued Andrx a new Form 483 after a reinspection of the drugmaker’s Florida manufacturing plant, according to documents filed April 19 with the Securities and Exchange Commission (SEC).
The FDA faces numerous obstacles to implement a personalized approach to developing new medicines, including privacy concerns, financial limits and regulatory roadblocks, HHS Secretary Mike Leavitt said.