Regulatory Filings and Submissions

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Companies often wait for a critical mass before adopting new technologies. But if no one takes the risk, critical mass will never be reached.

The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information.

US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

More informed submissions may lead to regulatory flexibility for postapproval changes.

The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.

Utility patents are granted to anyone who invents any new and useful process, machine, article of manufacture, composition of matter, or any new improvement thereof.

Human infections with avian flu strain H5N1 are occurring in a number of southeast Asian countries that have experienced large outbreaks of avian influenza. How great a risk to the human population is posed by this virus, and what steps can be taken to minimize its impact? Preventive vaccines have great potential to avert the spread of avian flu and other infectious diseases. What are the factors affecting the creation of new vaccines, and how can they be optimized to promote public health?