Tag Archive: CROs

Sep 12

New FDA Guidances for August 2016

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in August 2016, are posted. One recent CDER Manual of Policies and Procedures (MAPP) regarding a change in hard gelatin capsule shell suppliers is included.  In addition, upcoming advisory committee meetings to be …

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Aug 17

A Brief Overview of the Use of Electronic Informed Consent in Clinical Investigations

by Rachael Gregg, B.A., Cato Research Clinical Research Associate   A Brief Overview of the Use of Electronic Informed Consent in Clinical Investigations The United States Food and Drug Administration (FDA) released a draft guidance “Use of Electronic Informed Consent in Clinical Investigations” in March 2015 that outlines recommendations for clinical investigators, sponsors, and institutional …

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Jul 06

FDA Revises Guidance on Special Protocol Assessments

By Harsh Sancheti, MSPS, MSRS, Ph.D., Medical Writer at Cato Research and Joanne McNelis, Ph.D., Scientist at Cato Research   FDA Revises Guidance on Special Protocol Assessments What is a Special Protocol Assessment (SPA)? SPA is a process where a study sponsor and the FDA reach agreement on the critical components of a stability protocol, …

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May 24

Looking for a FDA Breakthrough Therapy Designation (BTD)? Utilizing the Preliminary BTD Advice System Might be USEFUL – or NOT

By Harsh Sancheti, MSPS, MSRS, Ph.D., Medical Writer at Cato Research Looking for a FDA Breakthrough Therapy Designation (BTD)? Utilizing the Preliminary BTD Advice System Might be USEFUL – or NOT The Breakthrough Therapy Designation (BTD) process implemented by the US FDA facilitates expedited regulatory review of a drug candidate intended to treat a serious …

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Mar 16

Jump on the Development Safety Update Report (DSUR) Bandwagon!

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual Report format when it comes to their IND (sections 1.13.1 to 1.13.14 of the IND; …

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Jan 27

The FDA Wants To Hear Patients’ Voices

The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced the creation of its first-ever Patient Engagement Advisory Committee (PEAC) to advise the FDA commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. This marks a major …

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Nov 06

New FDA Guidances for October 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in October 2015, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information. Special Interest Guidances/Information Date Posted Liposome Drug Products: Chemistry, Manufacturing, and …

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Oct 13

One and Done: Are single pivotal studies the new norm in cancer therapeutics?

By Leanna Gentry, Ph.D., Fellow at Cato Research Clinical trials are a lengthy and costly component of drug development, with the vast majority of drugs failing to ever get to patients. Often, the efficacy seen in preclinical studies does not translate in clinical studies, and the drug fails to receive approval because of lack of …

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Oct 05

New FDA Guidances for September 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in September 2015, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information. Special Interest Guidances/Information Date Posted E6(R2) Good Clinical Practice – Draft …

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Sep 17

Macaw, Beagle, or Python? How to Choose the Best Vendor for Your Investigational Product Supply Needs

By: Margaret Schubert, Sr. Investigational Product Specialist, Compliance Specialist, Cato Research What if you were looking for a new pet?  Would you simply go to the internet and pick out the first one that came up in an internet search? No, of course not. There are thousands of types of pets and different breeds and …

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