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
On September 8, the US Food and Drug Administration revised the guidance for industry Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, originally published in April 2021. 9 September 2021
Pharmaceutical
For many years, artificial intelligence (AI), in particular machine learning, have been touted as potentially transformational technologies for drug discovery and development. 16 August 2021
Biotechnology
A third pharma major in as many weeks has voluntarily withdrawn from an immuno-oncology indication, as the US regulator toughens its stance towards Accelerated Approvals. 8 March 2021
Generics
The US Food and Drug Administration issued a warning letter to Professional Compounding Centers of America (PCCA) for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs). 28 January 2021
Pharmaceutical
Despite dealing with the urgent need to evaluate vaccines, drugs and diagnostics tests relating to the COVID-19 pandemic, the US Food and Drug Administration cleared a bumper number of novel drugs last year. 6 January 2021
Pharmaceutical
The US Food and Drug Administration has announced it will require a Boxed Warning for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions. 24 September 2020
Biotechnology
Days after the US Food and Drug Administration issued an emergency use authorization (EUA) for the use of convalescent plasma in COVID-19, a key advisory panel has warned of a lack of evidence. 3 September 2020
Pharmaceutical
US Food and Drug Administration (FDA) Commissioner Stephen Hahn finds himself walking a tightrope between bowing to the political pressure to approve a COVID-19 vaccine and waiting till late-stage trial data proves that the product is safe and effective. 1 September 2020
Pharmaceutical
The US Food and Drug Administration on Sunday issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. 24 August 2020
Pharmaceutical
As part of its steps to enhance patient engagement, on June 23 2020, the US Food and Drug Administration (FDA) launched Project Patient Voice, a publicly-available website that shares information about patient-reported outcomes (PROs) from cancer clinical trials for marketed treatments. 6 August 2020
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