Nautilus Biotech Receives FDA Approval For Phase 1 Clinical Trial In The USA For Oral Belerofon, its Long-Lasting, ... (BioresearchOnline)
Nautilus Biotech, a leading biotechnology company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to carry out a Phase 1 clinical trial for Oral Belerofon in the USA

Device makers to discover what drug makers know (BizJournals)
If your company is involved with prescription drug manufacturing, you probably already know about the Food and Drug Administration's new Structured Product Labeling eXtended Markup Language (SPL XML) requirement. The FDA began applying this standard to the manufacture of drugs in November 2005, and many companies are finding that compliance is costly.