USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing
The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under...
USA – FDA issues long-awaited LDT final rule
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan...
USA – FDA issues three guidances to expand cancer clinical trial eligibility
The US Food and Drug Administration’s (FDA) has issued a trio of draft guidance documents that aim to promote greater participation and diversity in...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
USA – FDA recommends collecting ovarian toxicity data in cancer drug trials
The US Food and Drug Administration (FDA) is proposing sponsors collect ovarian toxicity data during cancer drug development. The agency said that cancer drugs...
USA – FDA finalizes BIMO electronic submission guidance
The US Food and Drug Administration (FDA) has finalized guidance for sponsors on electronically submitting data on drugs and biologics that the agency will...
USA – Researchers suggest FDA needs authority to require pediatric studies for orphan drugs
The US Food and Drug Administration (FDA) may need greater authority to require pediatric clinical studies for drugs, including orphan drugs, according to a...
USA – Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures
The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering...
Canada – Drug and medical device databases
This list of Health Canada's drug and medical device databases briefly describes the information available in each database. It does not provide an in...
USA – FDA updates guidance on promotional labeling and advertising of biosimilars
The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.
The...
