Open pharma – regulator talks “critically important” to ending shortages; FDA

By Nick Taylor

- Last updated on GMT

Related tags: Drug shortages, Pharmaceutical drug, Fda

Biopharma firms can overcome a hurdle to ending drug shortages by having transparent talks with the FDA, an Agency official said.

Early communication of supply disruptions is a centrepiece of US Food and Drug Administration (FDA) plans to tackle drug shortages and the Agency is actively encouraging biopharma firms to speak up.

We’re all in the business of making good, sound, risk-based, technically-driven decisions. One of the hurdles is…open, forthright communication​”, Jeffrey Baker, deputy director, office of biotechnology products at FDA, told

Baker said it is “critically important​” drugmakers play their part in ending shortages by partnering with the FDA and keeping it informed of any potential disruptions to supply. By understanding their manufacturing capabilities drugmakers can foresee problems and give the FDA advanced warning.

It all starts with thoroughly understanding processes and thoroughly understanding the capabilities and constraints of their manufacturing. When they have that understanding [manufacturers will] be able to anticipate and hopefully prevent drug shortages​”, Baker said.

Related topics: Regulatory & Safety, Regulations, QA/QC

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