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Pfizer said yesterday that it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic. Read More
Picking someone to helm the FDA is “legitimately difficult,” even in normal times, experts say, let alone during a pandemic, which may help explain why President Biden so far is keeping silent on when he will move to nominate a permanent agency commissioner. Read More
Sunstar Americas failed to file three years of annual product reviews with the FDA for an oral rinse and there were no product review protocols for the product, agency investigators said, in a Form 483, following an inspection of its drug and device manufacturing facility in Schaumburg, Ill. Read More
Specialty drug manufacturer Acella Pharmaceuticals is recalling dozens of lots of NP Thyroid tablets, a drug for treatment of hypothyroidism, after it was determined that the products did not meet potency standards, a recurring issue for the company that previously prompted FDA enforcement action. Read More
The number of gene, cell and RNA therapies continue to grow rapidly with almost 3,500 treatments in either the preclinical or clinical testing phases, a new report says. Read More