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US FDA Blood Pressure Risk Assessment Guidance Uses Unique Format

 
• By Michael McCaughan

As agency embraces bullet-point format, old-school draft full of call-outs and solicitations seems unlike anything before or since. Regardless of style, FDA's testing recommendations for developmental therapies are of broad, substantive interest to industry.

Hand points to business flow chart

Center for Drug Evaluation & Research Director Janet Woodcock believes that the US FDA has figured out how to get guidances out much more rapidly, touting a “just-say-it” approach that focuses on bullet points and key messages rather than longer, discursive text. (Also see "'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says" - Pink Sheet, 14 November, 2017.)

During the recent Food & Drug Law Institute annual meeting, in fact, Woodcock responded to a question about what is...

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More from US FDA

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.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

More from Agency Leadership

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

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.