Tag Archive: pre-IND

Jul 20 2012

FDASIA, Part 1: The “UFAs”

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 series, we will cover the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical Device Regulatory …

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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

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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Oct 25 2011

Pre-IND Submissions in eCTD Format

Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission.  However, since FDA assigns a Pre-IND number, which ultimately becomes the IND number, and Module 1 includes at least two places that are appropriate for including Pre-IND …

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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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Oct 26 2010

Vendor Selection – All that Glitters is Not Gold

One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities.  Several variables determine what makes a good outsourcing partner – size compatibility between CRO and sponsor, the cost, and the experience level of the CRO …

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Jun 02 2010

Guidance for the Therapeutic Discovery Tax Credit

Credit you give yourself is not worth having. – Irving Thalberg For all you virtual biotechs and small start-up biotechs that survived the “Great Recession,” here is something to look forward to.  I’ve mentioned the Therapeutic Discovery Tax Credit before, but only in passing.  Now, though, the FDA Law Blog has brought to my attention …

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Mar 08 2010

Nonclinical Program Considerations for a Pre-IND Meeting

Developing a well–thought-out nonclinical program is an evolving process.  The number and types of animal studies impact not only funding requirements, when an IND will be filed, and whether the IND will be cleared, but also what the starting dose in the clinic will be, and for long-term studies – whether submission and approval of …

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