In a letter addressed to FDA Commissioner Robert Califf, lawmakers expressed on Monday that the disparity in inspection results seems to be yet another instance of institutional deficiencies and dysfunction within the FDA's overseas drug inspection program.
The FDA also authorized Moderna’s vaccine for school-aged children and teens. Pfizer’s shots had previously been the only ones available for those ages.
The problems began last year as the COVID-19 pandemic led to disruptions in labor, transportation and raw materials — economy-wide issues that didn’t spare the formula industry. Inventory was further squeezed by parents stockpiling during COVID-19 lockdowns.
The findings are based on a study conducted by the FDA in collaboration with the US National Institutes of Health.
The FDA scientists said their review identified several potential risks, including possible toxicity and birth defects.
The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.
While the products can now be legally sold in the U.S., the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.
The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average.
An influential federal advisory panel overwhelmingly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.
The FDA has only granted emergency-use approval of the Pfizer, Moderna and Johnson & Johnson vaccines, but the agency is expected to soon give full approval to Pfizer.
Americans have managed to get COVID booster shots by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated.
US regulators on Monday added a new warning to Johnson & Johnson's COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it's not entirely clear the shot caused the problem.
Bharat Biotech's application for approval of indigenous COVID-19 vaccine, Covaxin, has been rejected by the US FDA that cited a lack of sufficient data.
FDA is expected to authorize Pfizer's COVID-19 vaccine for young adults age 12 and older by next week
A team of researchers has identified nine potential new Covid-19 treatments, including three, that were already approved by the US Food and Drug Administration (FDA) for treating other diseases.
Commissioner of the US Food and Drug Administration (FDA) Stephen Hahn has refused to offer a timeline for the COVID-19 vaccine, which US President Donald Trump suggested could be available "long before the end of the year".
The FDA said it was no longer reasonable to believe that oral formulations of hydroxychloroquine and the related drug chloroquine may be effective in treating the respiratory illness caused by the novel coronavirus.
Dr Reddy's Laboratories Ltd said the companys NDA (new drug application) Elyxyb ((celecoxib oral solution 25 mg/mL) has been approved by the US Food and Drug Administration.
A top Trump administration health official has said that as many as 19 therapeutics trial are underway and 211 in planning stages in a bid to find the cure for coronavirus.“We are leaving no stone unturned to find the treatment for COVID-19... We don't have any approved therapeutics for COVID-19 but we are actively involved with the academic, commercial and private sector to find it,” FDA Commissioner Stephen M Hahn told reporters at a White House news conference.
FDA said as of now it has issued an emergency use authorisation to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile (SNS) to be distributed and used in limited circumstances, such as for certain hospitalised patients with COVID-19.
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