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Information for industry

• FDA finalized the guidance for industry, Labeling for Biosimilar Products (PDF, 285 KB). This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing labeling for submission in proposed biosimilar product applications. A biosimilar product is a biological product that is approved based on a demonstration that it is highly similar to an FDA-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product.  Also see: Biosimilars Action Plan (PDF, 383 KB) (July 18, 2018)
• FDA issues policy to facilitate the use of electronic health record data in clinical investigations - FDA published a guidance for industry, Use of Electronic Health Record Data in Clinical Investigations(PDF, 327 KB). The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. (July 18, 2018)
• FDA's CDRH is announcing the 2019 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/input, and challenges that impact the medical device development life cycle. FDA invites medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding the ELP. Submit electronic proposals for participation in the ELP within the dates provided at the ELP website. (July 30, 2018)
• Reminder: Comments are due on the draft guidance for industry, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention (PDF, 120 KB) by September 10, 2018.
  

More: MCM-Related Guidance by Date