We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
HHS is creating a new task force to assist in determining ways to help speed the development of new medical technologies and drug compounds, Secretary Tommy Thompson said in a speech last week.
The FDA has reopened the comment period for a notice on time estimates for collecting information for reporting manufacturing changes on approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), citing a lack of industry input.
The FDA needs to clarify the distinction between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance to ensure drug manufacturers submit the appropriate data and avoid delays in product development, according to industry comments received by the agency recently.
The FDA’s efforts to close a loophole in enforcement actions on marketed unapproved drugs have pitted one drugmaker that argues the loophole punishes firms that apply for a new drug application (NDA) against another company that says closing the loophole will limit competition and drive up prices for the drugs.
Critics of the FDA’s proposed rule on in vivo bioequivalence (BE) data are wondering whether the agency can find the additional time and personnel needed to comprehensively review drugmakers’ BE data submitted in abbreviated new drug applications (ANDAs).
The FDA should issue stronger warnings related to the risk of suicide in children who take antidepressants, even as researchers at Columbia University work to clarify the data on the potential risks, an FDA advisory committee recommended yesterday.
Generic drugmakers Ivax and Dr. Reddy’s are scheduled today to start challenging a patent on drugmaker Eli Lilly’s top-selling schizophrenia drug Zyprexa (olanzapine).
With cracking down on the trafficking of counterfeit drugs a major priority, FDA will be hard pressed to finally implement the repeatedly stayed final paper pedigree rule this April and burden small distributors with the task of proving the source of their goods.
Drug distributors should be required to document where a drug product has come from and where it is going to at least one step in the distrubution chain until electronic track and trace technologies can be developed and adopted by the industry, Johnson & Johnson (J&J) told the FDA recently.
The U.S. drug supply chain should adopt a “one step forward, one step back” model of documenting drug products until electronic track and trace technologies can be developed and adopted by the industry, Johnson & Johnson (J&J) told the FDA.