Category Archive: Uncategorized

Mar 08

Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018

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By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic common technical document (eCTD) format. Section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act) authorizes the United States Food and Drug Administration (FDA) to …

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Jul 14

FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS (ICH E14 (R3)) in 2005. This month, FDA published the most recent ICH updated list of questions and answers (ICH …

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Jan 09

New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities …

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Oct 03

New FDA Guidances for September 2014

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 September, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information. Special Interest Guidances/Information Date Posted ANDA Submissions — Refuse-to-Receive …

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Jul 16

Effective Partnerships for Virtual Biotech Companies–how companies and partners can work efficiently together

Lisa R. Sanders, Ph.D., R.A.C., Sr. Clinical Scientist II at Cato Research No matter what you call it–outsourcing, contracting, partnering–for a virtual biotech, partnership is vital to success. Virtual companies face specific hurdles such as the lack of a central office and infrastructure, a small and often geographically dispersed workforce, undercapitalization, small pipeline, and a …

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Jan 30

FDA’s Comprehensive Status Report on Personalized Medicine

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA published a report, prepared by the Office of the Commissioner in the Office of Medical Products and Tobacco, in October 2013 entitled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development” with an enthusiastic forward by …

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Dec 05

A New Version of the Declaration of Helsinki

By Guest Contributor: Dawn Groenke, Senior Medical Writer at Cato Research In October, the World Medical Association adopted a new version of the Declaration of Helsinki.  This revision was completed prior to the 50th anniversary of this document (to occur in June 2014) and included updates on issues that have been under discussion in the medical …

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Nov 08

New FDA Guidances for October 2013

Plenty of new Guidances for October, including FDA’s thinking on development programs for acute bacterial skin and skin structure infections and the eCopy program for medical device submissions.  Also of interest this month is FDA’s position on the reclassification of hydrocodone containing drugs (released on 24 Oct 2013).  This has created substantial buzz in the …

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Aug 13

New FDA Guidances for July 2013

Another month with lots of new and updated guidances released.  Two guidances highlight clinical design considerations for specific therapies: Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases and Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products. Medical Device Reporting for Manufacturers Antibacterial Therapies …

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Jul 14

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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