A Florida doctor is the latest to plead guilty in connection with an Insys scheme to pay kickbacks in exchange for prescribing its opioid drug Subsys. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb urged internet stakeholders to help the agency crack down on illicit online opioid sales Tuesday as the FDA posted warnings sent to nine online operators of…
The FDA hit OTC oral gel manufacturer Europharma Concepts with a warning letter after finding significant CGMP violations at its facility in Clara, Ireland. Source: Drug Industry Daily
Sen. Ron Johnson (R-Wis.) requested a meeting with FDA Commissioner Scott Gottlieb to clear up “misconceptions” about the agency’s role in implementing the newly signed right-to-try legislation. Source: Drug Industry…
As part of its BsUFA II commitments, the FDA updated a 2015 draft guidance for biosimilar sponsors seeking formal meetings with the agency. Source: Drug Industry Daily
A new FDA pilot program would pre-review sponsors’ data submissions to reduce delays in oncology drug development, FDA Commissioner Scott Gottlieb said Saturday. Source: Drug Industry Daily
CDER Director Janet Woodcock outlined an ambitious plan to reorganize the center’s drug reviews by centralizing project management under the Office of New Drugs. Source: Drug Industry Daily
The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Source: Drug GMP Report
The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Source: Drug GMP Report
The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may…