Chelsea Took Proactive PR Approach For Northera Panel, But Will It Help Or Hurt?
The company held an investor presentation 10 days before the meeting to rebut criticisms laid out in FDA’s briefing document about the droxidopa safety and efficacy data. Immediately following the meeting, Chelsea hosted an investor call, during which the company’s external cardiology consultant criticized the FDA clinical reviewer as “naive.”
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At its Feb. 23 review of Chelsea Therapeutics’ investigational orthostatic hypotension drug droxidopa, FDA’s Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome.
“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says
Office of New Drugs director says the agency is seeing more small, inexperienced companies traveling the drug development and approval pathway on their own. However, these firms need more advice from the agency and are all too eager to publicly share their one-sided view about these regulatory interactions.