Tag Archive: GMP

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 12 2012

Meningitis Tragedy Leads to Calls for Increased FDA Oversight

On 25 September 2012, three lots of steroid injections intended to treat pain were recalled by the pharmaceutical compounding company New England Compounding Center (NECC) in Framingham, MA, because of fungal contamination.  By Thursday, 11 October 2012, 12 people had died and there were 137 confirmed cases of fungal meningitis due to contaminated injections.  The …

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Aug 15 2012

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

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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Jul 09 2012

Unique Device Identifiers: It’s the Law, Almost

When the FDA Amendments Act was signed into law in 2007, one of its many tasks was to create a Unique Device Identifier (UDI) system.  On 03 July 2012, the FDA released the proposed rule for UDIs. The UDI is a code, similar in theory to a barcode, that will be printed on each device …

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Jun 12 2012

PET Drugs – Time to file that NDA, ANDA or IND

No more Nice Guy.  FDA is stopping Enforcement Discretion for facilities producing positron emission tomography (PET) drugs for clinical use effective Tuesday, 12 June 2012. The long and tortured history of PET Drug products regulation began in 1997, when Congress passed the Food and Drug Administration Modernization Act (FDAMA).  One of the sections in this …

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May 21 2012

Stem Cells: Which Way to the Clinic? (Updated!)

For over two decades, the potential of stem cell therapy to cure some of our most devastating diseases has been touted by the media.  A Google search of “stem cell research” yields over 57 million results, and yet, in mid-2012, there is only one approved stem cell product on the market in the United States …

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Nov 02 2011

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to lag behind and often do not recognize that project management is not too complex or …

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Jul 14 2011

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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