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The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics. Read More
An FDA advisory committee voted 10-0 in favor of the efficacy of a drug candidate for treatment of glaucoma and ocular hypertension based on data from efficacy trials. Read More
Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers. Read More
The Association of Clinical Research Organizations warned that the state of New Jersey’s plan to cap drugmaker payments to doctors could hurt clinical trials. Read More
The European Medicines Agency outlined its thoughts on the use of evidence generated through clinical extrapolation techniques in regulatory assessments, in a draft reflection paper. Read More
Most life sciences companies plan to significantly step up their use of real-world data sources over the next three years, according to a new survey by the Tufts Center for the Study of Drug Development. Read More
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More
The FDA could further improve the transparency of its benefit-risk assessments in drug regulatory decisions by disclosing more information in complete response letters, BIO suggested in written comments to the agency. Read More
The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the European Commission, the agency said in an action plan. Read More
The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay and how to request reconsiderations of fee assessments. Read More
Commissioner Scott Gottlieb said there’s no better time for him to work at the FDA, with a slate of new agency authorities providing a “watershed opportunity” to shape the regulatory process. Read More
The plan’s objectives cover early dialogue and scientific advice processes, information exchange at market entry and generating data following product authorization. Read More