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Mashup Score: 1
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1Master Protocols Offer Another Avenue To Advance Real-World Evidence - 7 month(s) ago
Experts discuss how master protocols can help produce more comparable real-world evidence and draw more investigators into studies. FDA CMO Hilary Marston says payers must be more involved in discussion of the value of real-world data.
Source: pink.citeline.comCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1ARPA-H, US FDA Discuss Incentives For Game-Changing Health Projects - 7 month(s) ago
Because the Advanced Research Projects Agency for Health can reimburse FDA for services, the two agencies are discussing what that could be available, such as priority assessments, when the projects reach the application stage.
Source: pink.citeline.comCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1Califf’s New Spin On US FDA Staffing: Attrition Rate Is Too Low - 9 month(s) ago
Commissioner also talks drug shortages, difficulty getting key agency and industry priorities done in new pandemic legislation, and how legal challenges to FDA authority could impact pharma companies desire to develop new medicines.
Categories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1Pharma Spent Record Amount on Lobbying in 2022 - 1 year(s) ago
Our infographic breaks down the biggest contributors, recipients and legislative targets.
Source: Pink SheetCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1
A November 2022 refuse-to-file letter cited clinical and statistical issues for the stem cell therapy, which failed its Phase III clinical efficacy endpoint. However, BrainStorm has consistently asserted that NurOwn demonstrated benefit in patients with less advanced disease at baseline, and it is encouraged by regulatory flexibility FDA recently has shown for the neurodegenerative…
Source: Pink SheetCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1
Center for Drug Evaluation and Research plans to issue a request for information this year to engage stakeholders on issues related to AI and machine learning. It received 175 AI/ML submissions in 2022, up from 14 in 2020.
Source: Pink SheetCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1The Long And Short Of Accelerated Approval Accountability In US - 1 year(s) ago
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
Source: Pink SheetCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1Piloting Real-World Evidence: US FDA RWE Demonstration Projects - 1 year(s) ago
Agency offers three informal ‘buckets’ organized around data, study design and tools.
Source: Pink SheetCategories: Latest Headlines, Rare DiseaseTweet
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Mashup Score: 1
Hilary Marston discusses medical misinformation, orphan drug approvals, and her deep list of responsibilities at FDA in an interview with the Pink Sheet.
Source: Pink SheetCategories: Latest Headlines, Rare DiseaseTweet
RT @PharmaPinkSheet: Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts https://t.co/8pa2yMkuPJ #PinkSheet