Tag Archive: drugs

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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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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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 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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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.

Jun 09 2010

FDA & NIH Launch Electronic Safety Reporting Portal

Biology will relate every human gene to the genes of other animals and bacteria, to this great chain of being. – Walter Gilbert The FDA and the NIH have announced a joint venture called the Safety Reporting Portal (SRP).  The SRP is a website for reporting safety data (pre- and post-market) in compliance with U.S. …

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Jun 03 2010

FDA Ups the Ante on Transparency

Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s most recent move on the subject really takes the cake.  If you are in any …

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