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The FDA hit a Tijuana drug manufacturer with a warning letter for shoddy investigations into microbiological contamination and other serious violations observed during an agency inspection. Read More
A U.S. court has ruled in favor of the FDA in a case filed by Vanda Pharmaceuticals alleging the agency didn’t provide an adequate scientific reason for a partial clinical hold issued in December 2018 for the company’s long-term study of tradipitant. Read More
In the wake of declaring the coronavirus a global emergency, the World Health Organization (WHO) has issued a new procedure for drugmakers that wish to submit unapproved drug products for public health crises. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended fifteen drugs for approval at its first meeting of the year, including four generics and one biosimilar. Read More
Sponsors of biologics and biosimilars should carefully consider how they present safety and efficacy information in their promotional materials, the FDA said in a draft guidance released yesterday. Read More
A majority of consumers and physicians believe generic drugs are inferior in quality to branded products, FDA officials said at a National Press Club event in Washington, D.C., yesterday. Read More
More drugmakers have unveiled plans for countermeasures against the coronavirus as experts forecast that the outbreak is almost certain to become a pandemic. Read More