USA – Patients with incurable cancer should be included in trials for new therapies
The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational...
USA – FDA issues final guidance on ANDA CRL, Orange Book
The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to...
USA – FDA final guidance targets neonatal pharmacology studies
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is...
USA – FDA guidance focuses on Real-Time Oncology Review program
How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.
For...
USA – FDA describes plans to expand remote regulatory assessments
The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated...
USA – FDA offers new guidance on therapeutic equivalence evaluations
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...
USA – FDA guidance targets dose banding information in drug labels
The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in...
UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark...
For the first time ever in the UK, postmenopausal women will be able to access a low dose Hormone Replacement Therapy (HRT) product from...
USA – Legislation could catalyze EU pharma industry innovation
The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...
USA – Guidance : Instructions for Use — Patient Labeling for Human Prescription Drug...
This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological...
