Currently, the standards TGO 91 and TGO 92 establish the rules for the information that companies must include on the labels of prescription and over-the-counter (OTC) medicines, respectively. The TGA ...

The US Food and Drug Administration (FDA) on Thursday issued warning letters to 12 manufacturers and retailers for illegally marketing breast binders to children for gender-affirming surgery. The ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, the ...

During the second meeting of the US Food and Drug Administration@s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with ...

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

The US Food and Drug Administration (FDA) has published three draft guidances on developing cell and gene therapies (CGT) to treat rare diseases, conducting postapproval CGT studies, and using the ...

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...

The US Food and Drug Administration (FDA) on Monday published final guidance to assist sponsors in identifying the appropriate supplement category for biosimilar prior approval supplements @ both ...

The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2026 across its prescription drug, generic drug, biosimilar, and medical device programs. The rates are ...

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to propose an indefinite recognition of CE-marked medical devices and new pathways to get devices on the market that have ...

The US Food and Drug Administration (FDA) on Friday began the reauthorization process for the next iteration of the Generic Drug User Fee Amendments (GDUFA IV) with a public meeting to gather input ...