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The FDA is getting closer to releasing a guidance that will address the scientific challenges in creating generic biologics and provide a foundation for a possible legal and regulatory framework for approving the complex treatments.
To ensure drugmakers submit appropriate data and avoid product development delays, the FDA should distinguish between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance, according to industry comments submitted to the agency.
The pharmaceutical industry’s interest in early-stage compounds for drugs in the pipeline may create new opportunities for biotechnology companies to supplement their research and development efforts, according to the participants in a panel discussion held at the BIO CEO & Investor Conference in New York City yesterday.
Legislation pending in the House intended to fix a patent law problem, which has had a chilling effect on collaborative research between industry and universities, could produce some unintended problems of its own, according to the Biotechnology Industry Organization (BIO).
Biologics manufacturers will have 30 days to formally request a meeting with the FDA to discuss when the agency refuses to consider a biologics manufacturer’s product application, the agency stated in a guidance issued at the beginning of the year.
The FDA approved 25 new biotechnology drugs and biologics in 2003, up 25 percent from the year before, the Biotechnology Industry Organization (BIO) said yesterday.