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Info Collection on OTC Drug Labeling

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Federal Register notice: FDA sends to OMB an information collection revision entitled General Drug Labeling Provisions and OTC Mon...

$2.25 mil. RWD Funding Opportunity

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CDER and CBER release a $2.25 million funding opportunity announcement to assess the potential utility of real-world data to gener...

CGMP Deviations Seen in Centrient Inspection

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FDA warns Indias Centrient Pharmaceuticals about significant CGMP deviations in its manufacturing of active pharmaceutical ingredi...

Clinicians Need Refresher on Clinical Trial Statistics: Survey

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Researchers conclude clinicians are challenged to interpret results from both Bayesian and traditional statistical outputs from cl...

Whats Behind the New LASIK Guidance?

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Attorney Jeffrey Shapiro says FDA appears to be trying to get LASIK laser manufacturers who have an approved PMA to submit a suppl...

Bill to Advance Pregnant/Lactating Women in Trials

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Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) introduce HR 9487, Advancing Safe Medic...

Assign TE Codes for All Approved Drugs: Study

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A Brookings Institution report suggests ways to speed FDA therapeutic equivalence ratings for injectable drugs approved through th...

Change Antibiotic Development Incentives: Study

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Harvard Medical School researchers call for new incentives to develop antibiotics that show added value for patients through clini...

Moderna/Merck Cancer Vaccine Meets Endpoint

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Moderna and Merck say their investigational mRNA cancer vaccine met its endpoint in a Phase 2b melanoma trial.

FDA Clears Bausch Contact Lens Rehydrating Drops

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FDA clears a Bausch + Lomb 510(k) for its Biotrue Hydration Boost Contact Lens Rehydrating drops.