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Paige Monborne

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Autism Feedback To FDA: Focus On Communication, Redefine 'Irritability'

US FDA’s 22nd Patient-Focused Drug Development meeting focused on the challenging disease of autism. It also showed how far FDA has come in embracing the patient-input process over the past five years.

Drug Approval Standards FDA

SMA Patient Meeting Showcases FDA Flexibility – And Appreciation From Advocates

US agency's top neurology review officials received warm reception during Patient Focused Drug Development meeting for Spinal Muscular Atrophy. They also delivered a strong message of continued engagement beyond the first drug approval.

Drug Approval Standards Research & Development

FDA Patient Feedback Meetings: External Model Ramping Up In 2017

US agency has started transitioning to a new model for Patient-Focused Drug Development meetings, with agency officials attending four externally hosted meetings so far, with at least three more planned for the next few months. So far, the Neurology Products Division has been particularly active with the external meetings.

FDA Rare Diseases

'OpenTrialsFDA' Could Allow Research On Product Approval Packages

Former FDA psychiatric reviewer and UK OpenTrials Group among finalists in NIH competition to create an open source and open data tool.

Clinical Trials Drug Review

A “Precedent-Setting” OTC Switch – And A Case Study In Disregarding FDA’s Advice

Galderma’s OTC switch application for the acne therapy Differin (adapalene 0.1% gel) cleared an important milestone with a unanimous vote in favor of approval from an FDA advisory committee April 15. FDA urged the committee to consider the application as “precedent setting” given the theoretical risk of teratogenicity – but one committee member was more worried about the bad precedent of approving an application for a sponsor that didn’t do a label comprehension study they way FDA requested.

BioPharmaceutical Prescription To Otc Switch

PRVs Revisited During Drug Pricing Hearing: FDA Still Doesn’t Like Them

It’s not what most people will remember from the event, but the Feb. 4 hearing on drug pricing included an exchange reinforcing FDA’s reservations about the priority review voucher program – including a quote from an interview published by The RPM Report.

BioPharmaceutical Legislation
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