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U.S. Department of Health and Human Services

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Product Applications (including Investigational Applications)

View PDF of the Product Applications (including Investigational Applications) Section (142 KB)


Background

Summary of Public Comments

Considerations

Transparency Report ArrowView All Product Applications (including Investigational Applications) Draft Proposals


Draft Proposals

Draft Proposal 8

FDA should disclose the existence and, when asked, confirm the existence or non-existence of investigational applications.  For investigational applications, the disclosure should include the name of the application sponsor, the date the application was received, the proposed indication(s) or intended use(s) of the product, and the proposed proper and/or trade name of the product, if available.


Draft Proposal 9

FDA should disclose: (1) whether an investigational new drug application (IND) has been placed on hold, terminated, or withdrawn, whether an investigational device exemption (IDE) has been terminated or withdrawn, or whether an investigational exemption for a new animal drug has been terminated and (2) if an IND has previously been placed on hold, whether and when the hold is lifted.  A statement should be included that such actions may be taken for various reasons, only some of which relate to safety or effectiveness. 


Draft Proposal 10

FDA should disclose the fact that an NDA, NADA, ANDA, ANADA, BLA, PMA, or 510(k) application or supplement was submitted (or resubmitted) to the Agency at the time the application is received by FDA.  The disclosure should include the name of the application sponsor, the date the application was received, the proposed indications or intended use of the product, and the proposed proper and/or trade name of the product, if available.


Draft Proposal 11

FDA should disclose that an unapproved NDA, ANDA, NADA, ANADA, BLA, or PMA, or uncleared 510(k) has been withdrawn or, if FDA determines that the application was abandoned, abandoned by the sponsor.  If the drug, biological product, or device is associated with a significant safety concern, FDA should provide a brief description of the product, the use for which approval was sought or obtained, and the identified safety concern. 


Draft Proposal 12

When an application for a designated orphan drug or a designated minor use/minor species animal drug has been withdrawn, terminated, or abandoned, FDA should disclose, if it determines, based on its review, that the application was not withdrawn, terminated, or abandoned for safety reasons and the product, if approved, could represent a significant therapeutic advance for a rare disease or for a minor animal species.  A disclaimer that provides that FDA’s expressed views about the product do not reflect whether a subsequent application involving the product will be accepted for filing or will be approved by FDA should accompany the disclosure of this information.


Draft Proposal 13

FDA should disclose the fact that the Agency has issued a refuse-to-file or complete response letter in response to an original NDA, BLA, or an efficacy supplement for an NDA or BLA at the time the refuse-to-file or complete response letter is issued, and should, at the same time, disclose the refuse-to-file or complete response letter, which contains the reasons for issuing the letter. 


Draft Proposal 14

FDA should disclose the fact that the Agency has issued a refuse to approve letter in response to a NADA, or a supplemental NADA to add a new species or indication, at the time the refuse to approve letter is issued, and should, at the same time, disclose the refuse to approve letter, which contains the reasons for issuing the letter. 


Draft Proposal 15

FDA should disclose the fact that the Agency has issued a “not approvable” letter in response to a PMA for a medical device and the fact that FDA has issued an “additional information (AI)” letter in response to a 510(k) submission, and should, at the same time, disclose the reasons for issuing the “not approvable” letter or “additional information (AI)” letter, which contains the reasons for issuing the letter. 


Draft Proposal 16

FDA should disclose relevant summary safety and effectiveness information from an investigational application, or from a pending marketing application, if the Agency concludes that disclosure is in the interest of the public health, which includes when FDA believes it is necessary to correct misleading information about the product that is the subject of the application.


Draft Proposal 17

FDA should convene a group of internal and external stakeholders to discuss the possible uses of non-summary safety and effectiveness data from product applications, the circumstances under which it would be appropriate for sponsors to disclose non-summary safety and effectiveness data from applications submitted to FDA, and if appropriate, the format and the method by which disclosure should occur.