The program aims to aid submissions from external stakeholders and FDA staff.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
On July 26, 2023, FDA released a guidance document on a program at FDA’s Center for Drug Evaluation and Research (CDER) to publicize a listing of accepted voluntary consensus standards that related to pharmaceutical quality. FDA wrote that its involvement in the development and use of technical consensus standards has been crucial to its mission. FDA has used its standards to “develop and/or evaluate performance characteristics of dosage forms, testing methodologies, manufacturing practices, product standards, scientific protocols, ingredient specifications, labeling of drug products, and other technical or policy criteria.”
The guidance document highlights the scope and purpose of the program, before going through the specific elements of the program, including openness, balance, due process, appeals process, and consensus. The document then addresses CDER’s policies and procedures for evaluating voluntary consensus standards, which are recognition request submission and communication with requestors, recognition request evaluation, and updating the CDER program’s recognized standards database. The document ends with a Q&A section, addressing queries such as where recognized standards are posted and how the CDER program will affect other FDA centers.
The CDER program aids submissions by external stakeholders and FDA staff who are proposing voluntary consensus standards that relate to pharmaceutical quality for recognition. In the document, FDA wrote, “CDER believes that this program will help promote beneficial innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications for products regulated by CDER.”
If an industry stakeholder references one of CDER’s accepted voluntary consensus standards with a product regulated by CDER, FDA may still request additional information to show that the standard was observed and is correct for the intended purpose. FDA wrote that the stakeholder’s use of a recognized standard is strictly voluntary.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
2 Commerce Drive
Cranbury, NJ 08512