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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

Eager But Wary: Industry Seeks More Useful, More Detailed Remote Regulatory Assessment Processes

Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods.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.

Manufacturing Quality

FDA Allowed Release Of Moderna COVID Booster While Still Mulling Plant Inspection Findings

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.

Coronavirus COVID-19 Vaccines

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Pharmaceutical industry groups pushed back on expansion beyond CARES Act requirements that agency proposed in draft guidance, saying it would increase the risk of drug shortages instead of reducing it.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