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The FDA is requesting postmarketing commitment studies more often, as they are becoming increasingly important in the drug approval process in the U.S., according to a recent study.
Guidances on the clinical evaluation or approval requirements for six classes of drugs were withdrawn last week because they are out of date and of little value to the industry, according to the FDA.
The FDA will use new “complete response” letters, instead of approvable letters or not-approvable letters, to indicate that the review cycle for new and generic drugs is complete but that the applications are not ready for marketing approval, the agency said last week.
A physicians' group is calling on Congress and the federal public health establishment to create incentives that will encourage drugmakers to invest more resources into R&D of antibiotic drugs to avert a looming public health crisis.
In regulations and policy statements where the term "available therapy" is not defined, the phrase should be interpreted as therapy that is specified in the approved labeling of regulated products, with only rare exceptions, the FDA said yesterday in a guidance that aims to clarify the term.
The FDA is withdrawing six guidances on the clinical evaluation or approval requirements for six classes of drugs because they are out of date and of little value to the industry, the agency announced yesterday.
HHS’ Centers for Medicare & Medicaid Services (CMS) announced that it is revising its Medicare coverage policy to remove barriers that prevent antiobesity treatments from being covered.
While the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way to establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs, according to PhRMA.
The Medicare prescription drug benefit that kicks off in 2006 could reduce the quantity of Rx drugs prescribed for low-income seniors because of the way the law is structured, according to a new report from the Kaiser Commission on Medicaid and the Uninsured.