Psychiatric drug safety isn't just about antidepressants any more. An increased risk of depression and suicidality is killing new drug prospects and has threatened multi-billion dollar franchises. FDA aims to help by injecting some clarity and predictability into the process. Now It's up to sponsors to take advantage of ithe FDA's initiatives.
Kate Rawson
Obesity drugs. Smoking cessation agents. Allergy and asthma products. Epilepsy medications. Urinary incontinence treatments. When it comes to the potential...
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The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
