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Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More
Amarin has sued the FDA, seeking five years of market exclusivity for its prescription fish oil drug Vascepa, which the agency last week granted only three years of exclusivity. Read More
The FDA says sponsors of antiretroviral drugs should submit clinical trial data sets that include patient data, endpoint data, genotypic data and phenotypic data when reporting data on HIV-1 resistance to the agency in support of an HIV drug. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
As calls for revoking the FDA’s approval of Zogenix’s painkiller Zohydro ER continue to grow, lawmakers are now questioning whether a public-private industry partnership tainted the agency approval process. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More