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Pharmaceutical
The US Food and Drug Administration (FDA) is reopening the comment period for the Federal Register notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry. 31 December 2024
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Latest News & Features of interest to FDA
Biotechnology
Scott Gottlieb, Commissioner of the US Food and Drug Administration, released a statement on Thursday discussing the role of probiotics and microbiota in the biologic landscape. 17 August 2018
Biosimilars
The world’s total expenditure on medicines was $1.135 trillion in 2017 and is projected to reach $1.4 trillion in 2022.1 Understandably, when contemplating such large figures, the reaction from governments, healthcare payers and the public has been to seek more value for every dollar spent, writes Dr Nicola Davies on her regular blog for The Pharma Letter. 13 August 2018
Pharmaceutical
The US Food and Drug Administration (FDA) has published new guidance promised to help cancer drug developers to bring their products to market more efficiently and more affordably. 10 August 2018
Pharmaceutical
As Novartis and now Merck & Co move to grab the price-cutting spotlight from Pfizer, US Health Secretary Alex Azar revealed a new approach to drug importation on Thursday that could have a more far reaching impact on prices. 20 July 2018
Biotechnology
Having last year announced its comprehensive policy framework for regenerative medicine, the US Food and Drug Administration (FDA) has this week unveiling complementary measures for the development, review and approval of gene therapies. 12 July 2018
Generics
Like other victims of a toxic US political environment, Obama-era FDA pick Robert Califf did not long survive the political turbulence of presidential election season. 11 July 2018
Pharmaceutical
With safety reviews underway in Europe and warnings for the Canadian regulator, the Food and Drug Administration is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. 11 July 2018
Pharmaceutical
The US Food and Drug Administration on Friday issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling. 9 July 2018
Biosimilars
Yesterday (June 21), the US Food and Drug Administration withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017, concluding that it could have proved too burdensome. 22 June 2018
Biotechnology
The US Food and Drug Administration (FDA) has added restrictions to the labels of two immunotherapy drugs for locally advanced or metastatic urothelial cancer patients who are not eligible for cisplatin-containing therapy. 21 June 2018
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