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The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated...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In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...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The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in...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...
USA – HHS issues guidance on legally prescribed drugs for abortion
The Biden administration on Wednesday said retail pharmacies and pharmacists must provide patients with the medication they were legally prescribed even if it could...
USA – FDA offers guidance on fit-for-purpose clinical outcome assessments
The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the...
USA – FDA releases 5-year action plan to combat neurodegenerative diseases
The FDA on June 23 announced a 5-year strategy for improving and extending the lives of people with rare neurodegenerative diseases by advancing development...
USA – FDA explains when it will rescind breakthrough designations
The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its...
