Regulatory Affairs

European Biosimilars Makers Seek More Appropriate Labeling Format

Europe’s biotech industry is pressing regulators to update guidance on labeling of biosimilars to include information on both the reference product and the biosimilar. The current practice of assigning a generic label is insufficient due to the products’ unique scientific and regulatory status, companies say. Read More

Texas AG Sues AstraZeneca for Off-Label Seroquel Marketing

The Texas attorney general has sued AstraZeneca over allegations the company illegally pushed off-label uses of its antipsychotic Seroquel, a move that comes four years after AZ paid hundreds of millions of dollars to settle similar litigation nationwide. Read More

EMA Proposes Secure System for Access to Clinical Trial Data

Regulators in Europe have proposed restricting access to certain information in a forthcoming clinical trials portal and database, but industry wants assurances that the system will be able to differentiate security access for different types of documents. Read More