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
Biotechnology
Outlook Therapeutics, a biopharmaceutical company working to develop and launch the first approved ophthalmic formulation of bevacizumab for use in retinal indications, has announced it has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010. 30 August 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a revised draft guidance for industry, which responds to frequently asked questions about FDA’s processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use. 23 August 2022
Biotechnology
French drugmaker Sanofi has paused recruitment for its global tolebrutinib Phase III trials following guidance from the independent data monitoring committee (iDMC), resulting in an almost 2% drop in its share price. 9 August 2022
Generics
The US Food and Drug Administration’s (FDA) Office of Generic Drugs has published its first progress report on the activities and accomplishments of the Global Generic Drug Affairs program’s Generic Drug Cluster. 1 August 2022
Generics
This week Kelly Del Dotto, principal at USA-based patent firm Fish & Richardson P.C., provides context on the all-important Orange Book. 30 June 2022
Pharmaceutical
The US Food and Drug Administration is looking to raise the issue of drug shortages, in an attempt to boost the resilience and effectiveness of drugmakers in ensuring continuity of supply. 20 May 2022
Pharmaceutical
The US medicines regulator has issued three final guidances to drugmakers regarding cancer clinical trials, reflecting a broader push from the administration to improve healthcare outcomes in oncology. 2 March 2022
Generics
The annual generic drug approvals by the US Food and Drug Administration have been falling since 2020, with 737 generics approved1 in fiscal year 2020 and 6792 in fiscal year 2021 – the latter being the lowest in five years. 18 February 2022
Pharmaceutical
The US Food and Drug Administration will have a new leader, after the Senate confirmed Robert Califf in a tight vote, 50 to 46, which exposed political divisions over a range of healthcare issues. 16 February 2022
Pharmaceutical
Since Donald Trump’s 2018 “American Patients First” plan, and long before, drug pricing in the USA has been both a lightning rod for strong opinions and stubbornly resistant to reform. 12 October 2021
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