New FDA Forms 356h and 1571

In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to include new data fields. FDA asks that all sponsors begin using these new FDA forms 356h and 1571 immediately; however, it … Continued

DIA’s RSIDM Ask The Regulators Session: What We Learned

DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the “Ask the Regulators” session, in which representatives from FDA answer questions directly from the attendees. This year, DIA scheduled two … Continued

The Ides of March—FDA’s Pharmaceutical and Clinical Pharmacology Advisory Committee Meeting

While ominously scheduled for March 15, no such drama (like the assassination of Julius Caesar, the origins of ‘beware the Ides of March’) occurred during the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. It was quite productive, acknowledging the tremendous impact of modeling and simulation in drug development and regulatory review moving the technology further into the mainstream.

How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards

Editor’s Note: This is the first in a series of posts related to the Identification of Medicinal Products (IDMP) written by CAPT Vada A. Perkins (ret) that will appear on the eCTD Summit. Mr. Perkins is the Founder and Managing Principal of IDENTIFICA, a global life sciences consulting and IT firm specializing in global product … Continued

CDISC Data Standards: Understanding the Guidance for Standardized Study Data

In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. The study data requirement is not retroactive and will only apply to … Continued

FDA to Introduce New Validation Errors for Study Data

FDA is planning to introduce new eCTD validation criteria it will use to enforce requirements for clinical and non-clinical study data submitted electronically. The study data validation errors (2 High, 2 Medium) will apply to the following eCTD sections – 4.2 Study Reports and 5.3 Clinical study reports and related information. FDA is asking sponsors … Continued

Rolling eCTD Submissions a Good Fit for Expedited FDA Programs

The idea of a rolling submission, or rolling review, for a Biologics License Application (BLA) or New Drug Application (NDA) is not new. In fact, the concept was introduced as the U.S. Food & Drug Administration (FDA) implemented the Modernization Act of 1997. A rolling submission is done in waves. Sponsors submit completed sections for … Continued

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