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JCVI advised the UK government to adopt Pfizer’s Comirnaty and Moderna’s Spikevax for the autumn booster program in addition to Moderna’s bivalent COVID-19 vaccine for adults, with Novavax’s recently approved vaccine as backup. For adolescents, JC...

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The US Food and Drug Administration (FDA) on Tuesday finalized its guidance explaining its policies for replacement reagents and instrument families for in vitro diagnostics (IVDs), replacing an earlier policy issued in 2003.

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Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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The US Food and Drug Administration has developed draft guidance for manufacturers of hydrogen peroxide-based contact lens care products (HPCP) to consider when labeling their solutions in response to a number of adverse events, including cases wh...

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In the first year and a half of the COVID-19 pandemic, public funding played a major role in the development of COVID-19 therapeutics and vaccines, according to recent research published in JAMA Network Open .

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RAPS will recognize the recipients of each award at RAPS Convergence 2022.

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The Regulatory Affairs Professionals Society (RAPS) has named 10 exceptional senior regulatory professionals to the distinguished ranks of the RAPS Fellows Program.

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The US Food and Drug Administration (FDA) issued a warning letter to Emergent BioSolutions subsidiary Cangene BioPharma outlining violations of current good manufacturing practice (CGMP) regulations found during a February 2022 inspection of their...

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After pressure from the Biden Administration, the US Food and Drug Administration finalized a much-anticipated rule that allows certain air conduction hearing aids to be available over-the-counter (OTC) without the need for a hearing exams or fitt...

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Immune checkpoint inhibitors (ICIs) improve patient-reported outcomes (PROs) if they are used alone or together with other anticancer drugs, according to recent research published in JAMA Network Open .

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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The effort is based on Philippine FDA’s push to increase reliance on the work of other regulators. Last year, the World Health Organization released a document on good reliance practices that supported the use of the output of other regulatory age...

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