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Reforms proposed by the National Institutes of Health (NIH) intended to head off employee conflicts of interest in performing outside consulting work do not go far enough to remedy the problem, according to a report by the U.S. Office of Government Ethics (OGE).
Fears that changing the formula for calculating reimbursements for Rx drugs through Medicare will significantly reduce the volume of cancer drugs prescribed for patients are probably exaggerated, according to a drug industry analyst.
The FDA is proposing to amend the final monograph for OTC nasal-decongestant drug products to remove the indication “for the temporary relief of nasal congestion associated with sinusitis” and to prohibit use of the terms “sinusitis” and “associated sinusitis” elsewhere in the labeling.
Proposed regulations implementing the prescription drug savings available through the Medicare discount drug card were announced by HHS Secretary Tommy Thompson last week.
Proposed regulations implementing the prescription drug savings available through the Medicare discount drug card were announced by HHS Secretary Tommy Thompson yesterday.
The FDA intends to discontinue the use of approvable letters and not-approvable letters for drug marketing applications and instead use “complete response letters” to indicate the review cycle is complete but the application is not ready for approval, the agency announced yesterday.