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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
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
The European Medicines Agency (EMA) has released new guidance on the use of good manufacturing practices (GMPs) in the production of biological starting materials for advanced therapy medicinal products (ATMPs). Read More
On May 1, revisions went into effect on the Pharmaceutical Inspection Co-operation Scheme (PICS) Good Manufacturing Practices Guide, addressing the manufacturing of advanced therapy medicinal products (ATMPs) in addition to biological medicinal substances and products. Read More
In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance. Read More
The FDA and industry groups have laid out their initial proposals in several negotiation meetings ahead of the third authorization of the Biosimilar User Fee Act (BsUFA) that will cover fiscal 2023 through 2027. Read More
Worldwide drug spending — excluding spending on COVID-19 vaccines — is projected to increase by 3 percent to 6 percent at a compounded annual growth rate through 2025, climbing to $1.6 trillion, fueled primarily by oncology and immunology development, says a new report from IQVIA. Read More
The FDA has withdrawn a Trump era policy aimed at improving transparency by requiring the agency to publish more information on drug review timelines. Read More