On 2, 2025, President Trump signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction ...

The bill prohibited the FDA from enforcing regulations aimed at increasing traceability of the supply chain, among other ...

Trump administration officials, including Health Secretary Robert F. Kennedy Jr., have discussed scaling back the role of ...

Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed “unnecessary.” 1 The goal of these moves, according to the agency, is to make ...

The appointment of Pazdur as CDER head comes shortly after the surprise ousting of George Tidmarsh and should quiet many of ...

The government isn’t the only arbiter of product quality.

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The Supreme Court will hear oral arguments on Monday in a dispute over the Food and Drug Administration’s rejection of two companies’ applications to sell flavored liquids for use in e-cigarettes. A ...

The FDA has posted a summary of Novo Nordisk (NVO) site inspections made over several dates in March of this year at the company’s Drug Substance Manufacturing Site in Kalundborg Sjalland 4400 DK.