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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 53 websites for illegal marketing and sale of opioids including tramadol and oxycodone. Read More
Gottlieb said before the law’s passage that if additional patient protections did not make it into the final bill they could be passed “administratively” without compromising the intent of the law. Read More
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. Read More
A new FDA pilot program would pre-review sponsors’ data submissions to reduce delays in oncology drug development, FDA Commissioner Scott Gottlieb said Saturday. Read More
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. Read More
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 require such labels. Read More
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More
The state may file lawsuits against additional defendants depending on the outcome of current investigations and settlement talks, according to the AG’s office. Read More