Why Medical Writing Services Use Style Guides & Lexicons
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
Tag: 規制関連
DIA MASC
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using … Continued
FDA Draft Guidance on Planned PMR/PMC Forms 3988 & 3989
What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information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 … Continued
What’s the Difference between Anonymization and Redaction of Clinical Trial Data?
When it comes to disclosing data from clinical trials of investigational drugs to the public, the vernacular may seem just as confusing as the process! The terms “anonymization” and “redaction” are used interchangeably regarding transparency and disclosure of clinical trial data. But what are the differences in technique or method behind each? We may think … Continued
Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others boast a less formal, less structured process. You need to select a vendor who will help to maintain … Continued
CCI/CBI: How to Identify Confidential Information in Regulatory Submissions for Investigational Drugs
Outside of protecting study participants’ personal information (PI) within clinical research publications, pharmaceutical organizations should avoid disclosing company-related secrets and procedures which could aid their competitors in gaining market advantage. This type of information is called Commercially Confidential Information (CCI) by the European Medicines Agency (EMA) or Confidential Business Information (CBI) by Health Canada (HC). … Continued
Fixing Q-Submission Errors that Prevent FDA Acceptance of Medical Device Submissions
You are initiating the journey of submitting your Medical Device Application to the FDA and want feedback from the agency on your planned application. How do you communicate your questions related to your planned application to the FDA? The answer to that question resides with the agency’s pre-submission program for medical devices, the Q-Submission (Q-Sub) … Continued
Understanding CTIS: Europe’s New Clinical Trial Information System
After almost twenty years with EudraCT, it’s time to say goodbye to Europe’s old clinical trial database and embrace the new Clinical Trial Information System (CTIS). CTIS will be the single-entry point for submitting, assessing, authorizing, supervising, and reporting a clinical trial in all Member States of the EU (Figure 1). It will be used … Continued
A Patient Engagement Platform to Enhance Clinical Trial Transparency
Recruiting and retaining participants for clinical trials of investigational drugs has become increasingly difficult in recent years. Trial enrollment is dropping. One major reason patients cite for this dwindling participation is their lack of engagement and understanding of the clinical trial process. Why would patients volunteer their time and energy to a trial when scientific … Continued
