FDA streamlines sterility test requirements for biomedicines
The US Food and Drug Administration (FDA) has streamlined its sterility test requirements for approving biological medicinal products for sale on the US market.
Saying it has responded to a call from President Barack Obama to ensure regulations did not unnecessarily restrict business, the FDA has scrapped certain sterility test methods, culture media formulae and culture media test requirements.
Its new testing guidelines have also altered the storage and maintenance requirements for cultures of test organisms, allowing manufacturers to check only once per product lot where initial alerts of microbial contamination can be shown as being caused by laboratory error or problems with test materials.
In a communiqué, the FDA said: ‘The [administration] recognises the role innovation plays in bringing safe and effective products to market in a timely and cost-effective manner. The action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.’ It said the goals of the reforms were greater flexibility for biological medicinal product manufacturers while protecting consumer safety.
The move follows January’s presidential Executive Order 13563, which mandated the US government and its agencies to review and eliminate unnecessary regulations that inhibit innovation.
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