Departing FDA interim commissioner Janet Woodcock identifies some priorities she hopes incoming commissioner Robert Califf will continue pursuing.
Federal Register notice: FDA draft guidance provides IND clinical recommendations for Individualized Antisense Oligonucleotide Drug Products.
Federal Register notice: FDA makes available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for ...
Pfizer says it will submit full Paxlovid anti-Covid trial data to FDA in a few days.
FDA publishes an updated Clinical Outcome Assessment Compendium.
A Cleveland Clinic study says sildenafil may have a treatment benefit for Alzheimers patients.
Anti-dental amalgam activists savor a victory as Dentsply Sirona the worlds largest manufacturer of dental products exits the amalgam market.
The Association for Accessible Medicines says it appreciates an FDA guidance aimed at reducing the controlled correspondence workload.