February 6th 2024
GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.
November 2nd 2023
New laws leave consumers unprotected against third parties accessing their genetic data.
October 13th 2023
Agency will be reorganizing field force and compliance functions.
September 27th 2023
Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.
EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.
FDA Resumes In-Person Meetings with Industry…Sort Of
Face-to-face meetings will now include in-person and virtual components.
FDA Seeks to Simplify COVID Vaccination Program
Agency panel backs the use of a common bivalent shot for all patients.
Reviewing FDA’s Proposed IRB and Informed Consent Rule Changes
21st Century Cures Act prompts FDA to harmonize regulations.
One Week Left for CTIS Mandatory Use Date
EMA reminds the clinical trials community that the Clinical Trials Information System will be mandatory at the last day of this month.
Get it Right Next Time? EU Legislation Under Critical Review
The issues engulfing compliance with the Clinical Trials Regulation signal that even the best intentions with these types of laws may not be enough to avert unintended consequences.
Top Considerations for IRT Audit Data Management
Webinar Date/Time: Tue, Feb 21, 2023 11:00 AM EST
Summary of EMA’s Recommendation Paper on Decentralized Clinical Trial Elements
Latest recommendation places great emphasis on patients.
A New Year, a New Clinical Trials Committee—with Global Reach
WHO in midst of forming group focused on developing guidance on best practices in clinical trials.
Congressional Probe of Alzheimer’s Drug Hits FDA Interactions with Industry
House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.
Countdown to Mandatory European Clinical Trials System
With compliance deadline at end of month, concerns over readiness remain.
Decentralized Guidance Is the Best That Europe Can Do for Decentralized Clinical Trials
Despite agreement on recommendations between European regulators, DCT unclarity remains.
Massive Government Spending Bill Tackles Key FDA and Research Issues
The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.
Tips on Sponsor and CRO FDA Inspections
Michelle Webb, vice president of the WCG Avoca Quality Consortium, discusses her perspectives on FDA's revised overview of inspection activities.
Regulators Speak About Decentralized Clinical Trials
Insights from second annual DTRA meeting indicate DCTs are here to stay.
The Impact of Automated Safety Document Distribution on Pharmacovigilance and Patient Safety
Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.
Simultaneous New Drug Submissions: Is it Possible?
A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.
Key Guidance Updates in 2022
Summarizing important FDA and EMA revisions issued this year.
Tips and Tools to Overcome DE&I Challenges in Clinical Trials
Navigating FDA’s draft guidance and heightened diversity recommendations.
Europe’s Debate on AMR Becomes Another Proxy War Over Money
Debates caught between focusing on existing antibiotics and developing new agents.
Pandemic Spurred New R&D Approaches from Pharma, FDA in 2022
Looking back on major FDA moves in 2022.
Advice on Preparing for Regulatory Inspections
Marci Macpherson, executive director, quality assurance and compliance at Ionis Pharmaceuticals, discusses her perspectives on inspection readiness.
Real-World Evidence Makes Further Headway in Europe’s Healthcare Planning
Inaugural group of members added to EMA’s new data network focused on RWE.
Bringing Further Certainty into Platform Trials in Europe
New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies.
Major FDA Reform Unlikely in Closely Divided Congress
Following closely contested election, approval of FDA bills most likely tabled until new year.
‘Dogma’ About Innovation vs. Access Impeding EU Fixes for Rare Diseases
Rare disease stakeholders speak out ahead of anticipated EU changes.
Virtual Medical Affairs Audits: A Viable Alternative
Virtual audits proving to be beneficial post-COVID despite continuing challenges.
Pressure Mounts for FDA to Reform Accelerated Approval Program
Potential drug removal spotlights latest debate over the expedited pathway.
Pushing and Dragging the New European Clinical Trials Rules into Shape
Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.
A Pervasive Patient Focus in EU Clinical Trials as New Rules Face Fine-Tuning
New EU clinical trial regulation places heavy importance on patient-submitted documents.
“Culture of Quality” In Action
Sheri Kuss, clinical quality group lead at Pfizer, discusses the new "culture of quality" in clinical trials.