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Patient-Focused Guidance Writing: FDA Aiming For 'Sweet Spot' In Advice

 
• By Kate Rawson

US FDA’s first guidance on patient data collection methods will be ready by June, and agency wants to get the tone right from the start; agency assures stakeholders it will be “flexible” on accepting new tools.

FDA entrance sign 2016

The US FDA wants to ensure that its promised series of guidances on patient input are drafted with a new target audience in mind: patient advocates who may be new to the regulatory process.

That point was driven home during a Dec. 18 public workshop ahead of the release of the first draft guidance...

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More from Approval Standards

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

More from Pathways & Standards

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.