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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 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The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1.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
In what seems to be part of the lead up to the departure of the UK from the European Union, the European Medicines Agency laid out how sponsors holding orphan drug designations should go about transferring their EMA registrations from one country to another. Read More
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers Tuesday. Read More
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating the evidence needed for both agencies. Read More