New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program
By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs)...
Exception from Informed Consent in Emergency Research
by Reshma Jagasia, Ph.D., Scientist by Nicole Tackmann, Ph.D., Clinical Strategy Intern All clinical investigations conducted in the United States...
Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate Submitting IND safety reports to an IND in eCTD format is slightly different...
Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA
By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission...
Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products
By: Robert McNeill, Ph.D., Scientist In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for...
South Africa is Transitioning to a New Regulator of Medicines and Medical Devices
By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World, South Africa On 01 June 2017,...
FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies
Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist The International Conference on Harmonization (ICH) last updated its guidance “THE...
Compassionate Use: providing cancer care outside trials
Being a challenging and arduous operation, finding new therapies to treat cancer often is a time-consuming process. For some patients, marketed...
CANCER IMMUNOTHERAPY: A NEW HOPE
By Reshma Jagasia, Ph.D, Scientist at Cato Research The current standard of care for cancer treatment is surgery, chemotherapy, and...
A New Expedited Review Designation: Regenerative Advanced Therapy
By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist One of the many changes brought by the 21st Century Cures Act...