The groups on the front lines of the opioid epidemic may not be physicians or pharmacists or drug wholesalers, but they are the ones that need to receive naloxone if it is to do any good. Latest US FDA guidance removes one of the impediments.

US FDA’s Donald Ashley recaps past year’s precedent-setting responses to COVID-19 pandemic in interview, while outlining return to pre-COVID priorities and traditional inspection-based oversight.

Pharmaceutical industry groups pushed back on expansion beyond CARES Act requirements that agency proposed in draft guidance, saying it would increase the risk of drug shortages instead of reducing it. One group went further, objecting to cGMP regulatory creep into the supply chain.

Experts who led PDA’s interactions with EU, PIC/s and WHO authorities on first-ever comprehensive revision of sterile drug product manufacturing guidance recently shared insights on implementation priorities with the Pink Sheet.

The HHS agency hopes to bring together private sector teams that could quickly defend the US against future infectious outbreaks. The plan also calls for working with commercial lenders for the capital required to expand production of medical countermeasures.

HHS agency would expand on DOD consortium approach that delivered the COVID-19 vaccines to bring together private sector teams that could quickly defend the US against future infectious outbreaks. Plan also calls for working with commercial lenders for the capital required to expand production of medical countermeasures.