Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.

Memo outlines how US agency ensured sufficient delivery of updated COVID-19 vaccine doses even as it navigated unresolved inspection findings of the Catalent plant where the additional doses had been manufactured.

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Pharmaceutical industry groups pushed back on expansion beyond CARES Act requirements that agency proposed in draft guidance, saying it would increase the risk of drug shortages instead of reducing it.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.