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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.

Latest From Bowman Cox

Opioid Emergency Clears Supply Chain Security Impediments To Naloxone Distribution

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.

Manufacturing Distribution

Time To Focus On GMP Activities Deferred By Pandemic, CDER Compliance Director Says

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.

OTC Drugs Manufacturing

Industry Calls For Narrower, More Flexible Supply Risk Planning Program Than US FDA Proposed

Pharmaceutical industry groups pushed back on expansion beyond CARES Act requirements that agency proposed in draft guidance, saying it would increase the risk of drug shortages instead of reducing it.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

Manufacturing Supply Chain

Sterile Drug GMPs: CCS Tool Could Help Bridge Compliance Gaps As Annex 1 Revisions Take Effect

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.

Manufacturing Quality

BARDA Proposes New Consortia For Rapid Pandemic Response

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.

Policy Coronavirus COVID-19

For Next Pandemic, BARDA Proposes New Consortia For Rapid Response

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.

Manufacturing Supply Chain
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