For today’s regulatory professionals, continuous audit readiness is essential. With evolving standards like ICH E6 (R3) and increased global scrutiny, being inspection-ready every day ensures ...
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 ...
Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific ...
The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency@s ...
During a public meeting on onshoring the production of drugs in the US on Tuesday, stakeholders called for improvements to the US Food and Drug Administration@s (FDA) recently launched PreCheck ...
Several stakeholders have raised concerns that parts of the US Food and Drug Administration@s (FDA) draft guidance on unique device identifier (UDI) requirements for combination products are ...
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 ...
Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world ...
@The US Food and Drug Administration@s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
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 ...
Health and Human Services (HHS) Secretary Robert Kennedy Jr. announced on Wednesday that the Emergency Use Authorizations (EUA) for all COVID-19 vaccines have been rescinded, coinciding with the ...
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