Changes to an Approved Application for

For an approved application (NDA, ANDA, or BLA), a change to a container closure system, to a component of the container closure system, to a material of construction for a component, or to a process involving one of the above must be reported to the application. The filing requirements are specified under 21 CFR 314.70 (supplements and other changes to an approved application) for an NDA or ANDA, and under 21 CFR 601.12 (changes to an approved application) for a BLA. 

Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products, 1997. http //www.fda.gov/cber/gdlns/chbiosyn.pdf... 

Code of Federal Regulations, Title 21, Food and Drugs, Part 314, Applications for FDA approval to market a new drug or antibiotic drug, Subpart B, 314.70 Supplements and other changes to an approved application. 

Food and Drug Administration. Guidance for Industry, Changes to an Approved Application Biological Products, FDA, Rockville, MD, 1997. 

Center for Biologies Evaluation and Research. Manual of Standard Operating Procedures and Policies, SOPP 8411.1. Changes to an Approved Application. Administrative Handling and Review of Annual Reports, March 10,1999. 

Amendments to an unapproved application Withdrawal by the applicant of an unapproved application Supplements and other changes to an approved application Procedures for submission of a supplement to an approved application... 

It is not required to have prior FDA approval to use an alternate method to a compendial test. According to 21 CFR 314.70, Supplements and Other Changes to an Approved Application, the addition or deletion of an alternate analytical method does not require prior approval and may be filed in the Annual Product Report. However, we would need to document the equivalency of the alternate method to the regulatory or compendial test method and the validation report must be available for an FDA investigator to inspect at our manufacturing site. Where the test method is particularly novel it may be advisable to include the test in an NDA supplement so the FDA can review the new method and your company can get prior FDA approval before the new test method is implemented. 

CFR Part 314.70. Supplements and Other Changes to an Approved Application. FDA Guidance for Industry Scale-up and Postapproval Changes for Modified Release Solid Oral Dosage Forms, Sep 1997. 

Changes to an approved device that could affect its safety or effectiveness must be submitted to the FDA as a supplemental application. These include changes to the indications for use, changes to the labelling, packaging or sterilisation procedures. 

An applicant should file a 505(b)(2) application if it is seeking approval of a change to an approved drug that would not be permitted under section 505(j), because approval will require the review of clinical data. However, section 505(b)(2) applications should not be submitted for duplicates of approved products that are eligible for approval under 505(j) [see 21 CFR 314.101(d)(9)],... 

In Japan, all these pathways to reduce ease the burden of introducing new excipients are more complex. If not already approved as a pharmaceutical excipient in Japan, food additives for oral administration or cosmetic substances for external application in drug formulations requires that they be treated as new excipients. For excipients already used in orally or intravenously administered products, a change to an externally applied product necessitates additional safety testing. Studies include acute and subacute toxicity (including adsorption through the skin) and local irritation investigations. ... 

The introduction is a brief statement regarding the development of the HASP. It should include the applicability and limitations. In this section, a statement is typically made that sets the stage for the safety plan and disallows any changes to the document without an amendment being completed and approved. 

The more comprehensive CEN standard makes it likely that an approved device is available for almost any application. In certain difficult applications it may be required to make modest design changes in order to accommodate the flame arrester and its capabilities, but this is preferable to being stuck with an application where no approved flame arresters are available. 

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