CDER SBIA Webinar on Postapproval Changes that may be Documented in Annual Reports

CDER SBIA will present a webinar entitled 'Postapproval Changes Related to Drug Product Quality, Manufacturing and Controls that may be Documented in Annual Reports', on Monday 12 May 2014, at 2 pm EDT.

On 4 March 2014, FDA/CDER published its “Guidance for Industry on CMC Postapproval Manufacturing Changes to be Documented in Annual Reports.” This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval changes that FDA has determined will likely have a minimal potential to adversely affect the approved product quality and, therefore, should be documented by applicants in an annual report.

The guidance lists examples in the following categories of CMC postapproval manufacturing changes previously submitted under manufacturing supplements that the FDA has determined generally to be of low risk to product quality:

• components and composition of the drug product

• manufacturing facilities

• manufacturing process, batch size, and equipment

• changes in the specification of drug product and its components

• changes in the container/closure system of the drug substance and/or drug product

• labeling changes to revise information related to CMC changes discussed in the guidance

• miscellaneous changes related to the stability testing of drug substances and drug products.

This guidance will facilitate the reporting of such changes, thereby leading to a proportional reduction in the number of supplements submitted to the Agency.

To register for this Event, please go to https://collaboration.fda.gov/sbia0512/event/registration.html