Combination Products/ Botanical Drugs/ Electronic Regulatory Submissions/ Reporting and Requirements under Sections 503A and 503B of the FD&C Act

1. Postmarketing Safety Reporting for Combination Products

This final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as ‘‘constituent parts’’ of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. 

2. Botanical Drug Development; Guidance for Industry

This guidance document describes the CDER’s current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This guidance specifically discusses several areas in which, due to the unique nature of botanical drugs, the Agency finds it appropriate to apply regulatory policies that differ from those applied to nonbotanical drugs, such as synthetic, semi-synthetic, or otherwise highly purified or chemically modified drugs, including antibiotics derived from microorganisms. 

3. Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information; Draft Guidance for Industry
This draft guidance discusses the requirements and implementation of the Federal Food, Drug, and Cosmetic Act regarding valid electronic submissions of manufacturing establishment information (MEI). Twenty-four months after this draft has been finalized, MEI contained in NDA, ANDAs, BLAs, and amendments, supplements, or resubmissions of these application types must be submitted electronically in the format specified in this guidance. This draft guidance also applies to drug master files that are submitted for incorporation by reference into an NDA, ANDA, or BLA.

4. Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry

This guidance document explains how facilities that elect to register with FDA as outsourcing facilities are to submit drug product reports, consistent with section 503B of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). It describes who must report and what information they must provide and explains that drug compounding reports must be submitted in structured product labeling (SPL) format using FDA’s electronic submissions system. 

5. Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry

This guidance sets forth the FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use (or office stock).

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

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