Biotech Values

[genisi]

Bolar exception

A partial list of acts in which this has been extended to:

Manufacturing a device or drug; selling to institutions/hospitals to obtain PMA; testing or selling the device to international distributors for clinical trials; demonstrating the device at a trade show. (in Intermedics). Exporting the reference standards for commercial development overseas; conducting purity and safety testing; producing scaled up amounts of the drug in the U.S.; characterizing the drug (in Amgen). Using a patented process; submitting data for foreign regulatory approval after it was first submitted to the FDA (in NeoRx). Conducting product research & development activity “upstream” in product development (in Bristol-Myers Squibb).