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FDA’s Suggested Acetaminophen Allergy Warning Tracks Industry Change

 
• By Eileen Francis

The recommendation in a draft guidance covering single- and combination-ingredient acetaminophen products marketed under the tentative final monograph for internal analgesics mirrors a warning that some OTC manufacturers already are using on their products.

FDA suggests manufacturers add allergy warnings to labels of acetaminophen-containing OTC monograph products due to a risk of rare but serious and potentially fatal skin reactions, including Stevens-Johnson Syndrome.

The recommendation in a draft guidance published Nov

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Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.