Premarketing Risk Assessment
Guidance for Industry – Premarketing Risk Assessment, Clinical/Medical
Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy
Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide…
M4S: The CTD — Safety
International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary)
Research in Progress | Office of Prescription Drug Promotion (OPDP) Research
Research in Progress | Office of Prescription Drug Promotion Research
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute pain…
Drug Trials Snapshots: BIMZELX
BIMZELX is an anti-interleukin (IL)-17A and IL-17F monoclonal antibody that is indicated for the treatment of adults with moderate to…
Drug Trials Snapshot: LIVTENCITY
LIVTENCITY is a prescription medicine used to treat cytomegalovirus (CMV) infection and disease.
Drug Trials Snapshots: LEQSELVI
LEQSELVI is a Janus kinase (JAK) inhibitor that is indicated for the treatment of adults with severe alopecia areata (AA).