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For the Moderna option, children between six months and five years old can receive a single bivalent booster dose two months after completing the primary series. Read More
Manufacturers of parenteral nutrition (PN) products should determine the amount of aluminum in small-volume parenterals (SVP) as well as large-volume parenterals (LVP) to ensure PN products do not exceed the recommended daily limit, according to a new FDA draft guidance that clarifies key factors in determining the aluminum content in SVPs. Read More
Four years into a multidistrict class action lawsuit, a federal court judge has dismissed 1,189 of the 2,000 lawsuits charging that Merck’s Zostavax shingles vaccine caused either the disease or shingles-related injuries. Read More
FDA Commissioner Robert Califf predicts the agency’s largest area of expansion over the next five years will be in the regulatory apparatus for reviewing cell, regenerative and gene therapies. Read More
The FDA plans to prioritize its enforcement and regulatory actions against specific homeopathic drug categories that pose a significant risk to public health, the agency said in a final guidance. Read More
The FDA has added a Sun Pharmaceutical facility in Gujarat, India, to an import alert following an agency inspection, but is exempting 14 products to avoid potential shortages. Read More
The FDA rapped independent testing lab Valisure in an untitled letter for violating the Drug Supply Chain Security Act (DSCSA) and for “methodological deficiencies” in its testing protocols, disputing the company’s claims that its pharmacy business was not subject to FDA regulation. Read More
The FDA has issued two proposed rules on investigational new drug applications (IND) that would require more detailed IND reports and exemptions for clinical trials for drug uses of a food, dietary supplement or cosmetic product. Read More