FDA removes a clinical hold against UniQures hemophilia B gene therapy program after determining it satisfactorily addressed all issues identified by ...
Becton, Dickinson files a 510(k) for the BD Alaris System that updates the infusion pump to address FDA regulatory issues raised last year.
The House Energy and Commerce Health Subcommittee announces a 5/4 hearing to discuss legislative proposals to lower prescription drug costs.
FDA announces a 6/9 workshop entitled The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021.
FDA says it supports increasing use of pharmacometric models in drug development because they allow a better understanding of drug effects in individu...
FDA Review posts the Federal Register notices for the week ending 4/23/2021.
The International Conference for Harmonization posts for adoption a revised guideline entitled ICH Q3C(R8) Guideline on Impurities: Guideline for Resi...