USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of...
USA – House report finds Trump officials sought to influence FDA during COVID pandemic
Officials in the Trump administration pressured the US Food and Drug Administration (FDA) during the first year of the COVID-19 pandemic to make regulatory...
USA – FDA allows sponsors to spread out costs in revised IND charging guidance
The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...
USA – FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients...
USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
The US Food and Drug Administration (FDA) on Wednesday authorized bivalent COVID-19 vaccines targeting the Omicron BA.4/5 subvariants developed by Pfizer-BioNTech and Moderna, asserting...
USA – European, US guidance differs on API nitrosamines
HARDLY A DAY goes by without mention of a newly emerging active pharmaceutical ingredient (API) nitrosamine, eg, nitrosamine propranolol.1 This has led to a great...
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The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to...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...
