Tag Archive: generic drugs

Jul 16 2012

New Provisions in the FDA Safety and Innovation Act (aka PDUFA V)

Seal of the U.S. Congress

On 09 July 2012, President Obama signed FDASIA (otherwise known as PDUFA V) into law. The reauthorization of PDUFA V has been working its way through both houses of Congress since May and has received uncharacteristically broad bipartisan and bicameral support. In 2007, PDUFA IV was hotly debated between the two chambers and was barely passed in time to replace the expiring PDUFA III, but this time, lawmakers were able to meet their goal of sending the President a reconciled bill well before the 30 September expiration date of PDUFA IV.

The new law will go into effect on 01 Oct 2012 and will sunset on 30 Sept 2017.

The FDASIA includes the following provisions

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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Mar 09 2012

After all the talk, where are we with biosimilars?

Biosimilars

In this highly charged political climate, no news broadcast is complete without some mention of healthcare.  Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. …

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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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Jul 27 2010

Generic Lovenox – Moving One Step Closer to Biosimilars

We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic.  It is derived from a biological source (pig intestines, yum), but it is not protein-based.  However, the FDA’s approval of a generic form has a rather interesting bearing on the future of biosimilars. But first, the basics:  Lovenox …

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Apr 19 2010

Drug/Biologic/Device Highlights from the Health Care Reform Bill

Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions in the Patient Protection and Affordable Care Act (commonly known as the “Health Care Reform …

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