FDA Rx PREGNANCY LABELING TASK FORCE PREPARING GUIDANCES on "interpretation of reproductive and developmental toxicity data from animals" and on "interpretation of human exposure data," the agency said in a July 31 Federal Register notice. The agency task force "will also consider other possible actions that may be necessary to make pregnancy labeling content more consistent, informative and accessible," the notice states.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
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.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
