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CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)

What’s New

What is the CDER Quality Standards Program?

The CDER Quality Standards Program will help promote innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications for products regulated by CDER.

A voluntary consensus standard is a:

'...document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.'

This program, established by publication of the final guidance for industry titled, Center for Drug Evaluation and Research’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, helps external stakeholders and FDA staff submit voluntary consensus standards related to pharmaceutical quality to CDER for potential recognition.

This program is intended for all drugs, including brand, generics, biologics, biosimilars, and over-the-counter drugs. It will help create efficiencies in generic and biosimilar manufacturing which is an important part of streamlining generic and biosimilar development and spurring competition as part of our Drug Competition Action Plan (DCAP) and Biosimilars Action Plan.

This program allows CDER to communicate to external stakeholders that FDA experts have evaluated a consensus standard and determined that the standard is potentially useful to industry and FDA staff.  The program also provides transparency to industry regarding CDER’s thinking about a certain method or approach.

Recognized Standards

Date of Recognition FDA Tracking Number Recognition Number Extent of Recognition Standard Developing Organization Standard Designation Number Standard Title
03/19/2024 SR 00077581 2024-001 Complete ASTM E3247-20 ASTM Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
10/24/2024 SR 00185667 2024-002 Complete ASTM E3042-16 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment
10/24/2024 SR 00185671 2024-003 Complete ASTM E2888-12
(Re-approved 2019)		 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

Submitting a Request for Recognition

The CDER Quality Standards Program Submission Portal can be accessed at https://edm.fda.gov.

Requestors will need the following information to prepare a recognition request:

  • Name and contact information of the requestor
  • Full title of the published standard, including the name of the organization that developed the standard and any reference number and date
  • Brief identification of the testing or performance or other characteristics of the drug(s) or manufacturing process(es) that would be addressed by the recognition of the standard, and the applicability of the standard to pharmaceutical development, establishing quality criteria, and/or regulatory assessment

Contact Us

Specific questions about the CDER program:

CDER Compendial Operations and Standards Staff CDERStandardsCoordinationRequest@fda.hhs.gov

General regulatory information:

CDER Division of Drug Information

druginfo@fda.hhs.gov

(855) 543-3784 or (301) 796-3400

 

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