The Food & Drug Administration’s work on curbing abuse of long-acting opioids hasn’t lacked for outreach. The three-year long effort to develop a formal Risk Evaluation & Mitigation Strategy to help ensure appropriate use of products like Purdue Pharma’s OxyContin has involved input from two dozen different manufacturers, formal presentations by more than 75 outside stakeholder groups, and literally hundreds of public comments.
By Laura Helbling
The Food & Drug Administration's work on curbing abuse of long-acting opioids hasn't lacked for outreach. The three-year long effort...
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Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.
