Tag Archive: risk

Feb 08

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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Aug 07

FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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May 26

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

May 11

Conference Recap – BayBio 2011

The BayBio Annual Conference 2011 was held on 20-21 April 2011 in Burlingame, CA.  The event was attended by more than 1,000 San Francisco Bay Area biotech and life sciences professionals from over 400 companies. This year’s conference focused on funding trends and emerging markets in the life sciences industry.  In keeping with BayBio’s spirit …

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Apr 08

New FDA Guidances – March 2011

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in March 2011 (most links go directly to PDF documents). Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act …

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Jun 22

Free Webinar – Past, Present and Future of REMS: Can We Mitigate With Restraint?

Join Cato Research for a free educational webinar on Thursday, 24 June 2010 at 2:00 PM ET.  The webinar, titled Past, Present and Future of REMS: Can We Mitigate With Restraint?, will be presented by Jack Snyder, M.D., J.D., Ph.D., R.A.C.  Jack is a Clinical Research Physician and the Assistant Managing Director of Cato Research’s  …

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May 27

An FDA Perspective on Risk/Benefit

If a man is alive, there is always danger that he may die, though the danger must be allowed to be less in proportion as he is dead-and-alive to begin with. A man sits as many risks as he runs. – Henry David Thoreau Stop me if you’ve heard this before:  There is no such …

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May 10

Analysis of FDA Guidance on Adaptive Designs

In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s famous keynote speech on the topic accelerated interest on the topic. In the intervening years, …

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