lunes, 1 de junio de 2015

CDER SBIA Update: New Notices and Guidance Documents

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. FDA issues guidance on “established conditions,” reportable chemistry, manufacturing, and controls (CMC) changes for approved drug and biologic products
FDA has issued a notice in the Federal Register announcing the availability of a draft guidance for industry, entitled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.”
This guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application for a drug or biologic product constitutes an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to FDA.
A better understanding of established conditions could allow for a more effective post-approval submission strategy by the regulated industry and could provide FDA with pathways to better regulate post-approval changes by utilizing more flexibility and risk-based principles
The guidance defines established conditions as:
the description of the product, manufacturing process, facilities and equipment, and elements of the associated control strategy, as defined in an application, that assure process performance and quality of an approved product.
Determining which elements of a specific application will be considered established conditions will occur as part of the application review process and will depend on the level of product and process understanding, the applicant’s risk assessment activities, and the control strategy proposed by the applicant.
For those parameters determined not to be established conditions by FDA, changes can be implemented solely within the manufacturer’s pharmaceutical quality system, and without the need for submission of a supplement or notification in an annual report. 
Submit electronic comments on the draft guidance to

2. Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
FDA is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The rule amended FDA's postmarketing safety reporting regulations for human drugs and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is also announcing the availability of the Safety Reporting Portal (SRP), a Web-based electronic submission system, for the electronic submission of postmarketing individual case safety reports (ICSRs) of adverse events for human drug and nonvaccine biological products. FDA is delaying the compliance date for the final rule because FDA understands that not all persons subject to mandatory postmarketing reporting requirements who wish to use the newly available Safety Reporting Portal (SRP) will have the opportunity to register for an account and test the submission process prior to June 10, 2015, the effective date of the final rule.

3. Guidance for Industry; M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; International Conference on Harmonisation
This guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

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