Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
When the Veterinary Feed Directive (VFD) Final Rule was announced earlier this month by FDA, the accompanying press release called it a ‘major step towards judicious antibiotic use’ in veterinary medicine [1]. There are several elements which look good, at least on paper: As prescribers of any and all antibiotics it Continue reading Cattle and Pigs and Chickens, Oh Yeah!
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…
When Al Gore became a best-selling author with “An Inconvenient Truth” he warned about climate change. When it comes to antibiotic resistance and the current situation of “Bad Bugs, No Drugs”, there are many voices warning us about a return to the pre-antibiotic era. Why does it take so long Continue reading An Inconvenient Truth: Ciprofloxacin-Resistant Campylobacter