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In an effort to fund his massive $2 trillion plan to overhaul U.S. infrastructure, President Biden is proposing to come down hard on corporations with heavier taxes — and his tax strategy includes provisions to eliminate current overseas tax breaks and havens that would have a significant impact on the pharma industry. Read More
The case arose from a 2013 whistleblower lawsuit filed in the Eastern District of Pennsylvania by attorney and pharma activist Ronald Streck. Read More
In public comments, industry trade associations have largely welcomed the FDA’s efforts thus far to improve its process for reviewing and approving biosimilars under the Biosimilar User Fee Amendments (BsUFA) II program. Read More
The FDA has issued a Complete Response Letter (CRL) to San Diego, Calif.-based Acadia Pharmaceuticals for their supplemental New Drug Application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). Read More
The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring. Read More
The FDA is preparing to conduct what it’s calling the first-ever systemic study examining how pharmaceutical brand names influence perceptions about drug efficacy. Read More
The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs). Read More
Drug manufacturers need to document and report to the FDA if they haven’t been able to comply with postmarket adverse drug experience (PADE) reporting requirements during the COVID-19 pandemic, a former agency compliance official advised. Read More
The Government Accountability Office (GAO) released a new report warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools. Read More