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CDER's Generational Shift: Many New Reviewers With Little Experience

 
• By Kate Rawson

While the center for drugs has enjoyed an influx of new reviewers in the last few years, the hiring frenzy has resulted in a significant shift in CDER's makeup: 38% of reviewers in the Office of New Drugs have less than two years of on-the-job experience. Office of New Drugs director John Jenkins discusses the challenges with training the new recruits, and how industry should adapt

By Kate Rawson

The last two fiscal years have seen great gains in the number of new employees hired in FDA's Center for Drug Evaluation & Research, but the result is a relatively under-experienced staff: 38% of employees in both CDER and

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.