by Maya Caldwell | Aug 11, 2017
The number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase. Therefore, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license...
by Maya Caldwell | Aug 11, 2017
According to an updated list of Department of Health and Human Services rulemakings, the US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017. Proposed Rulemakings Among the proposals coming are...
by Maya Caldwell | Aug 9, 2017
After a little more than ten months into Fiscal Year 2017, the US Food and Drug Administration (FDA) is on pace to break its record for abbreviated new drug application (ANDA) approvals from last year.1 FDA has approved 633 generic drugs in FY 2017 according to the...
by Maya Caldwell | Aug 8, 2017
Last Thursday, an article was published in the New England Journal of Medicine in which former director of the US Centers for Disease Control and Prevention Thomas Frieden called for greater use of alternative data sources, other than randomized controlled trials...
by Maya Caldwell | Aug 7, 2017
The US Senate on Thursday, August 3rd passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years.1 According to RAPS, a spokesman...
