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US FDA Contracting Update: From Rating Site Quality Maturity To Blocking COVID-19 Scams

 
• By Bowman Cox

Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.

business
now the real work begins

The US Food and Drug Administration has been lining up contractors to help it with a variety of drug quality-related initiatives, most notably an ambitious effort to assess the quality management maturity of individual pharmaceutical manufacturing facilities.

The agency already has enlisted the help of St. Gallen University and Dun & Bradstreet for a survey-based study, while...

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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

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