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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

The Quality Lowdown: No Longer Stoppered By Pandemic, US FDA Finds Serious Problems

Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.

Manufacturing Quality

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

Responses to FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods.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

OTC Drugs Manufacturing

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Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods.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