Latest FDA News
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
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Latest News & Features of interest to FDA
Pharmaceutical
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 2024
Pharmaceutical
Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023
Pharmaceutical
In 1984, Congress passed and the President signed into law the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act. 21 November 2023
Generics
The US Food and Drug Administration has revised its Manual of Policies and Procedures (MAPP), in relation to suitability petitions for generic drug regulatory submissions. 3 October 2023
Generics
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Generics
The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access. 19 May 2023
Pharmaceutical
While the US regulator’s scientists have given a positive opinion for Innoviva’s (Nasdaq: INVA) new antibiotic, the details appear not to have impressed investors, with shares falling 5% on Tuesday. 19 April 2023
Pharmaceutical
Amid an ongoing epidemic of opioid abuse in the USA, the country’s medicines regulator has announced safety label changes for opioids aimed at ensuring their safe use. 14 April 2023
Biotechnology
Patient groups have expressed disappointment that USA-based drugmaker Eli Lilly has not been granted an Accelerated Approval for its Alzheimer’s disease candidate, donanemab. 20 January 2023
Biotechnology
Continuing its impressive rise, Dupixent (dupilumab) has secured US Food and Drug Administration approval for prurigo nodularis, a debilitating skin condition. 29 September 2022
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