Tag Archive: biologics

Apr 11 2014

AMP’d Up Search for Biomarkers

By Kathy A. Grako, Ph.D., PMP, CCRP, Senior Clinical Strategy Scientist In February the United States government announced a unique triad brought together to “accelerate the development of life saving drugs and to help identify new treatments and cures for diseases” under the Accelerated Medicine Partnership (AMP).  FDA and NIH have teamed up with 10 …

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Jul 18 2013

New FDA Guidances for June 2013

FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA.  Look for a review of “Expedited Programs for Serious Conditions––Drugs and Biologics” coming soon. New Guidances for June: Human Blood and Blood Components Intended for Transfusion or for …

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Apr 11 2013

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive interactions, interactive review, and missed MDUFA decision communications. Formal Meetings Between the FDA and Biosimilar …

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Feb 12 2013

Everything You Need to Know About Priority Review Vouchers: Part 1 of 2

The Basics, History, and Record of the Priority Review Voucher Program The Basics If your company’s goals include funding pipeline development or increasing speed to market you should, at least, be familiar with the concept of the Priority Review Voucher (PRV). A PRV would be aptly described as an obscure or esoteric regulatory curiosity by …

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Jan 30 2013

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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Oct 24 2012

Considerations for the Assessment of Pain in Non-Verbal and Pediatric Subjects

Studies of drugs, biologics or devices that are intended for use in pediatric populations fall under far more stringent guidelines than those intended for use in adults.  The issues with pediatric studies range from informed consent concerns to stricter risk-to-benefit analyses.  Another problem that can arise in these studies, is that very young children cannot …

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Oct 10 2012

Clinical Trial Reporting

On 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete …

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Aug 29 2012

Biomarkers: Where are We Today?

The 06 August 2012 announcement by researchers from Boston’s Brigham and Women’s Hospital reporting the identification of a blood biomarker that could lead to earlier diagnoses and perhaps an actual treatment for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, was of great interest to me.  First, my brother-in-law, at the peak of his very …

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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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May 02 2012

Across the Board Disqualifications for Clinical Investigators

The FDA issued a final regulation earlier this week (April 30th) that broadens the rules for clinical investigator disqualifications.

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