Commissioner Scott Gottlieb said there’s no better time for him to work at the FDA, with a slate of new agency authorities providing a “watershed opportunity” to shape the regulatory…
In what seems to be part of the lead up to the departure of the UK from the European Union, the European Medicines Agency laid out how sponsors holding orphan…
In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August…
The FDA granted its first-ever approval to a prescription pill containing a sensor that verifies ingestion via electronic detection. Source: Drug Industry Daily
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic…
The FDA cited a drug outsourcing facility in Bethlehem, Penn., for numerous compliance problems including inadequate computer security and lax labeling practices. Source: Drug Industry Daily
The FDA cited an Illinois provider of home infusion therapy for failing to meet sterile production standards, according to a warning letter from the agency. Source: Drug Industry Daily
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating…
The PTO’s Patent Trial and Appeal Board issued a final rule clarifying when attorney-client privilege is recognized during the inter partes review process — as well as which communications are…
President Trump announced his new pick for HHS secretary — former Eli Lilly executive Alex Azar — on Twitter Monday morning. Source: Drug Industry Daily