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
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Biosimilars
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
Pharmaceutical
A survey reflecting the opinions of more than 400 current and former US Food and Drug Administration (FDA) advisory committee members about issues i 13 August 2024
Pharmaceutical
The US medicines regulator has established a new Center for Clinical Trial Innovation (C3TI). 16 April 2024
Biotechnology
A preliminary report from the US Food and Drug Administration could raise concerns about the safety of new vaccines for respiratory syncytial virus (RSV). 5 March 2024
Biotechnology
New regulatory guidance will be of interest for the increasing number of drugmakers investing ever more R&D capital into antibody-drug conjugates (ADC). 1 March 2024
Biotechnology
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T cell therapies. 26 January 2024
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