Biosimilars Action Plan
To encourage innovation and competition in the market for biological products and facilitate the development of biosimilars and interchangeable biosimilars, FDA has developed the Biosimilars Action Plan (BAP). The plan outlines the Agency’s commitments and focuses on...The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
Podcast and newsletterPodcast Transcript Dr. Jeffry Florian, PhD – Associate Director of the Division of Applied Regulatory ScienceOffice of Clinical Pharmacology, Office of Translational Sciences I CDER | FDAFDA researchers are investigating the utility of...FDA approves pembrolizumab and berahyaluronidase alfa-pmph
On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous...Bulk Drug Substances
Compounders sometimes prepare drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in an FDA-approved drug, a state-licensed pharmacist or physician, or an outsourcing facility,...Frequently Asked Questions about Drug Shortages
FDA can help prevent or mitigate drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the...Escherichia coli Sequence Type 131-H22 in Parrots from Illegal Pet Trade, Brazil, 2024
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: University of São Paulo, São Paulo, Brazil (V.G.P. Rocha, F.B. Barbosa, T....Emergence of Bordetella holmesii–Associated Pertussis-Like Illness, Northern India, 2019–2023
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Nishant Shekhar, Deepa Sharma, Surajit Chakraborty, Rajesh Kumar, Rajneesh Singh Rawat, Nirmal...Detection of Immunity Gap before Measles Outbreak, Ho Chi Minh City, Vietnam, 2024
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Detection of Immunity Gap before Measles Outbreak, Ho Chi Minh City, Vietnam, 2024 Thinh Ong ,...Click To Verify Security & Validation
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