FDA seeks to streamline inactive ingredient database with industry input

Regulatory NewsRegulatory News | 21 March 2022 |  By 

The US Food and Drug Administration (FDA) wants to know how it should prioritize maximum daily exposure (MDE) information and whether it should remove dosage form information from its inactive ingredient database (IID). The move is part of the agency’s commitment to industry to streamline the drug database.
On 21 March the FDA published a notice asking drug makers and other stakeholders what it should do to streamline the IID. As part of the generic drug user fee amendment (GDUFA II) the agency committed to make the database more user friendly for drug makers.
The IID lists excipients found in approved drug products which is used by manufacturers when developing new drugs and generics. It provides data on inactive ingredients that the FDA has previously vetted, and allowed in specific levels, routes of administration and dosage forms in approved products.
“FDA has steadily increased the number of excipient records that display MDE with each publication of the IID, but not all excipients in the IID have MDE information,” the agency noted. “The inclusion of such information could enhance the ability of applicants to reference IID information in support of proposed levels of excipients in their drug products. In meetings with FDA, stakeholders have asked about FDA’s plan to prioritize the addition of MDE information and have suggested that FDA focus on specific excipients that the stakeholders consider to be of high priority.”
Regulators also use the database when reviewing premarket submissions and technical reviews of applications to decide whether the proposed level of excipients in a drug product are acceptable or will require more data. Knowing how excipients have been used in previous drug products can help sponsors get a better idea of what the FDA finds acceptable, but some have complained the database can be hard to use.

“Some stakeholders have expressed that the numerous records in the IID for each excipient can be confusing,” FDA said. “An excipient search can yield a lengthy list of dosage forms for each route of administration, which could make finding the most appropriate IID record to reference challenging. Some stakeholders have suggested that FDA could remove dosage form information from the IID to simplify searches.”
The agency, however, notes that it also understands how dosage form information can be helpful to some drug makers and that removing such information could actually hamper their drug development process.
To get a better understanding of how the IID database can be updated to best serve drug sponsors, FDA asks for input on four specific that it will use to inform its approach to updating the database:
  1. Should FDA focus on adding MDE information for certain excipients? If so, which excipients should be prioritized for inclusion of MDE information and why?
  2. Should FDA focus on prioritizing excipients used in certain categories of drug products (e.g., oral or topical products)? If so, which categories and which specific excipients used in those categories should be prioritized and why?
  3. Is dosage form information in the IID helpful to your drug development program? If so, please explain how dosage form information in the IID is used in your drug development program
  4. Is the current structure or format of the IID difficult to navigate? If so, how can it be improved?
Stakeholders interested in giving the FDA their two cents can do so by submitting feedback to www.regulations.gov by 20 June.
Federal Register notice


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Tags: GDUFA, generics, IID

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