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Already investigating whether the FDA withheld information about a possible link between child suicide and antidepressants, the chairman of the Senate Finance Committee has now expanded his inquiry into whether drugmakers withheld information pertinent to such a link from the FDA.
A consumer protection organization has called on the FDA to investigate AstraZeneca for allegedly delaying the submission of adverse event reports regarding one of its cholesterol-lowering drugs.
The chairman of the Senate Finance Committee, who is already investigating whether the FDA withheld information about a possible link between child suicide and antidepressants, has expanded his inquiry into whether drugmakers withheld information pertinent to such a link from the FDA.
The FDA is planning to commence a nationwide search for a director for its soon-to-be-created Office of Oncology Drug Products (ODP), according to FDA acting Commissioner Lester Crawford.
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 House Oversight and Investigations Subcommittee plans to hold a hearing Sept. 9 to look into how the FDA accepts or rejects the work of its researchers when considering drug approvals.
Two FDA advisory committees will meet jointly Sept. 13-14 to consider the agency’s analysis of the findings of a group of experts that examined study data on the effects of several antidepressants on patients.
The FDA issued a public warning July 30 to alert the public about counterfeit versions of a top-selling cholesterol drug and a generic painkiller sold recently by pharmacies in Mexico.
The FDA plans to implement a series of recommendations during the next half year on best management practices relating to the agency’s drug review process.