The International Council for Harmonisation (ICH) has announced the adoption of Annex 2 to the guideline on Good Clinical ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
While digital health technologies (DHTs) offer potential new ways to collect data in clinical trials, industry stakeholders ...
Draft guidelines from the European Commission aim to assist companies in determining whether their products, including ...
The US Food and Drug Administration (FDA) recently sent warning letters to two facilities in the United States and Mexico for ...
Office of Prescription Drug Promotion (OPDP) sent an untitled letter to QOL Medical to “false or misleading” claims made in ...
The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...
The US Food and Drug Administration (FDA) is more likely to approve drugs with an orphan designation that were indicated for ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
The European Commission has adopted a roadmap to phase out the use of animals in chemical safety assessments, including for ...
More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...
The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...
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