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Pink Sheet Pharma Regulatory and Policy Insights

Details: Global Pharma Guidance Tracker – October 2022. By Vibha Sharma. Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online. Guidance Documents Regulation International.

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Opioid Prescriber Education Program May Become Mandatory; …

Details: WebHaving a single source for education is also being evaluated. Agency has previously been concerned that a mandatory program might require a restricted distribution system. US …

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Upcoming COVID Vaccines Cmte. May Be More For Public …

Details: WebCast Members In US FDA’s COVID-19 Vaccine Advisory Committee. There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine …

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US FDA Advisory Panel Split On Value Of Education In Fentanyl …

Details: WebSome members feel more education has important role in risk management for transmucosal immediate-release fentanyl products, while others think further …

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Pink Sheet Podcast: Drug Pricing Reforms, Opioid Prescriber …

Details: WebSubject: Pink Sheet Podcast: Drug Pricing Reforms, Opioid Prescriber Education, China And FDA’s Project Orbis Add a personalized message to your email. …

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Product Reviews & Approvals :: Pink Sheet

Details: WebNew EU Approvals. By Neena Brizmohun. The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add five new …

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FDA Exploring Partnerships As Alternative To REMS Mandate For …

Details: WebSubject: FDA Exploring Partnerships As Alternative To REMS Mandate For Opioid Education Add a personalized message to your email. Cancel. Send. Please …

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Providers Still See Drawbacks To Opioid Education …

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Legislation :: Pink Sheet

Details: WebMakena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure …

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US FDA Plans Education Efforts As Humira Biosimilars Launch

Details: WebThe launch is considered a bellwether for the biosimilar sector because the treatment for rheumatoid arthritis, psoriatic arthritis, Crohn’s Disease and other conditions, remains a …

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US FDA/Industry Thinking PDUFA VIII Could Be A Hybrid Negotiation

Details: WebFDA Staffing, Resource Gaps Makes Applying COVID Learnings To Other Disease Areas Challenging. CBER Director Peter Marks hopes to run pilot programs that could convince …

› Verified 7 days ago

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REMS Integration Into Electronic Health Records To Be Tested By …

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US FDA Suggests ‘Enhancements’ To Opioid Blueprint; CE

Details: WebAccelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur. Biotech sponsors understandably discuss accelerated approval as an important …

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‘Opioids’ Is Missing From The US FDA’s Overdose Prevention …

Details: WebComing Soon: New US FDA Opioid Plan. Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing …

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FDA SCIENTIFIC EXCHANGE POLICY SHOULD FOCUS ON …

Details: WebFDA's draft concept paper on "Drug Company Supported Activities in Scientific or Educational Contexts" is "overly broad" in scope and should address only …

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Makena Randomized, Controlled Trial Proposal Shows Evolution In …

Details: WebMakena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure …

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Califf Urges Congressional Patience On Opioid Actions

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Pending Biosimilars :: Pink Sheet

Details: WebPast year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its …

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Opioid REMS Revisions Reflect Some, Not All, Stakeholder Concerns

Details: WebUS FDA Suggests ‘Enhancements’ To Opioid Blueprint; CE Providers Want ‘Flexibility’. The US FDA has some ideas for short-term improvements in the continuing education …

› Verified 6 days ago

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