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FDA Provides Draft Guidance Prior to Implementing New Forms 3988 & 3989

What you need to know about the FDA’s proposed new PMR/PMC forms The FDA has released guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The guidance … 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


Rules for Submitting Electronic DMFs to FDA, Health Canada

  Rumors of rules governing Drug Master File (DMF) submissions are swirling. I’ve heard a pair of questions lately. “Do I need to resubmit my DMF files in eCTD format?” “Should I resubmit my files electronically?” The answer depends on the agency. The U.S. FDA and Health Canada have each updated their submission requirements for … Continued


Updated Form FDA 1571

FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018. This new version includes a revision date of “(07/18)” in the footer of each page. A side by side comparison of this July 2018 version to the previous version … Continued


Updates to Common FDA Forms

We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including: Form FDA 356h Form FDA 1571 Form FDA 3674 The easiest way to ensure that you’re using the current version of … Continued


New FDA Guidance on Penalties Relating to ClinicalTrials.gov

By Carrie Mitchell and Jason Buck Recently, the FDA issued a guidance concerning the penalties for noncompliance with ClinicalTrials.gov requirements. Sponsors conducting clinical trials should understand and follow the requirements for registering trials and reporting the results on ClinicalTrials.gov. The requirements have been in force since 2007 and were part of Section 801 of the … Continued


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


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

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