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Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
The European Medicines Agency said there is no evidence linking Novartis’ influenza vaccine Fluad to a series of adverse events and deaths that prompted Italian officials last month to suspend nearly a half-million doses of the product. Read More
The FDA is requiring drugmakers to revamp their product labeling to include clearer information on the safe use of drugs and biologicals in pregnant women and nursing mothers, marking the first labeling requirement of its kind since the late 1970s. Read More
In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure. Read More
Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
The FDA has added a warning about risks of a rare brain infection associated with Biogen Idec’s multiple sclerosis drug Tecfidera, after the first confirmed death of a patient taking the drug. Read More
The FDA touted its approval of an abuse-deterrent, single-entity opioid yesterday and sought to beat back congressional criticism it has done little to curb prescription drug abuse. Read More
In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral.
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