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The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations.
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While drugmakers should not rely on a “Plan B” for validating suppliers, there are some steps they can take if they can’t conduct sufficient quality audits — primarily beefing up incoming acceptance activities, compliance experts say.
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The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities.
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Pressure from governments to lower drug prices risks undermining medical innovation, Bayer AG’s chief executive said on Wednesday, echoing complaints of other drug company executives.
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Thousands of Americans who suffer from multiple sclerosis (MS) might one day be able to take advantage of a drug that new research suggests is both safe and effective.
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An experimental drug can improve sociability in patients with fragile X syndrome and may be helpful as a treatment for autism, according to the authors of a new study.
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Glenmark Pharmaceuticals said Glenmark Generics had obtained tentative nod from the FDA for rizatriptan benzoate tablets, its generic version of Merck’s Maxalt tablets.
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A proposal to extend drug patents in Canada as part of a free trade pact being negotiated with the European Union provoked a backlash this week over fears it would push up health care costs.
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