Gerald Dal Pan indicated in an interview that the agency's safety systems as now constituted are generating the data needed and that so-called real-time surveillance, which is in place for COVID-19 vaccines and therapeutics, is not practical for all approved products.
Real-time surveillance for all approved drugs likely is not realistic or advisable for the US Food and Drug Administration, but can be switched on when necessary, Gerald Dal Pan, the director of the agency’s Office of Surveillance and Epidemiology, told the Pink Sheet in a recent interview.
The FDA has been conducting near real-time surveillance in specific situations for some time and Dal Pan indicated a selective...
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
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.
