Tag Archive: safety

Mar 16 2016

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 2016

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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Dec 21 2015

Toxicological/Safety Evaluation of Dietary Supplements Containing Vitamins and Minerals

By Harsh Sancheti, Ph.D., Medical Writer at Cato Research Dietary supplementation of certain vitamins and minerals has resulted in significant positive public health outcomes. Some notable examples include folic acid fortification in wheat or maize flour that has reduced the risk of neural tube birth defects and fortification of milk with vitamin D that has …

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May 11 2015

New FDA Guidances for April 2015

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 April 2015, are posted.  In addition, upcoming advisory committee meetings to be held in the next couple months are listed below with links to more information.  Special Interest Guidances/Information Date Posted Biosimilars: …

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Jun 18 2013

New FDA Guidances for May 2013

FDA released 10 guidances in May, including two Q & A guidances, which I always find helpful (Charging for Investigational Drugs Under an IND and Expanded Access to Investigational Drugs for Treatment Use).  Additionally, as directed by FDASIA, a guidance was released discussing Priority Review of Premarket Submissions for Devices.  Among other information, this guidance …

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May 21 2013

New FDA Guidances for April 2013

There were many new Guidances out in April.  Notably, changes in postmarketing periodic safety reporting are discussed in this guidance.  See CATO’s take on some of the changes in postmarket reporting here. SUPAC: Manufacturing Equipment Addendum  Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 …

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Feb 08 2013

The Changing Landscape of Postmarketing Safety Reporting

Drugs are approved for marketing on the basis of clinical trials that are, generally speaking, carried out on relatively small numbers of people.  The goal of these trials are to identify the risks inherent in taking a drug while also assessing the drug’s efficacy in the treatment of the intended indication.  However, once a drug …

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Nov 19 2012

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada’s Drugs Directorate that analyzed the need for an …

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Jun 06 2012

New FDA Guidances Released in May 2012

Here’s a list of the  guidances released by FDA in April 2012, compiled by Cato Research Scientist Elinore Mercer, Ph.D. Pediatric Information for X-ray Imaging Device Premarket Notifications (Draft) S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (Draft) …

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May 25 2012

PDUFA V: A Funny Sounding Name for a Very Important Bill (Updated!)

US Capitol

Can you say PDUFA (pŭ-dōō-fŭ)?  The United States Senate can.  A very partisan Senate showed uncharacteristically bipartisan support for the Prescription Drug and User Fee Act (PDUFA) V, voting on 24 May 2012 to reauthorize PDUFA by a 96 to 1 vote.  This reauthorization allows for a 6% increase in fees paid by drug and …

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