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In response to the growing controversy over the suppression of negative clinical trial data, Eli Lilly has announced it will disclose all clinical trial results for the drugs its sells on a public registry, beginning the fourth quarter of this year.
Postmarketing commitment studies are becoming increasingly important in the drug approval process in the U.S., and the FDA is requesting them more often, according to a recent study.
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.
After a drug has entered the marketplace, it is critical for manufacturers to collect safety data and assess risk based on observational data in order to evaluate and characterize a product's risk profile and to make informed decisions to minimize those risks, the FDA said in a draft guidance released last week.
Drugmaker aaiPharma overstated its 2003 revenues by an unspecified but material amount as a result of booking revenue from consignment and other nonfinal sales, the company revealed Tuesday in an announcement outlining the results of a two-month investigation by the nonemployee members of its board of directors.
Legal experts speaking at a recent industry conference warned drugmakers not to “get ahead of the FDA” in making safety and efficacy claims about pipeline products in light of recent changes in the way the agency and the Securities and Exchange Commission (SEC) share confidential information about drug approval procedures.
The FDA last week defended its decision to not allow an agency expert to testify about his conclusions concerning a possible link between the use of some antidepressant drugs and an increased risk of suicide in young people taking the medications.
The FDA has set its regulatory sights firmly on the dietary supplement industry, saying it will more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe, just one week after issuing its final rule banning supplements containing ephedra took effect.
The FDA has issued a pharmacovigilance draft guidance that provides the foundation for a critical component of early postmarketing activities conducted by drug manufacturers, according to industry experts.
Justice Department officials have notified Eli Lilly that they have begun a civil investigation into the way the drugmaker markets and promotes its products, Lilly announced yesterday.