Posts Tagged ‘FDA’

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

Friday, July 8th, 2016

Tfda officehe FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this post.) The strategies involve the generation of reliable diagnostic conclusions for patients based on one or, oftentimes, many many mutations that are compared to those of other patients and to reference databases. Under “Scope,” the FDA has stated:

“[T]his paper discusses factors and principles to identify genetic databases that are of sufficient quality to support a regulatory submission…..[T]his paper discusses data quality and database operations as applied to the clinical interpretation of human genetic variants, i.e., for establishing the link between variants and the risk or diagnosis of disease or other states of health.”

(more…)

Why Did the Chicken Cross the Road? To Get New Genes!

Thursday, December 10th, 2015

chickenJay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes:

On December 8, 2015, FDA issued a complex set of approvals for a unique product, Kanuma (sebelipase alfa).  Kanuma is indicated for the treatment of a rare disease known as lysosomal acid lipase (LAL) deficiency.  The list of distinguishing descriptors for the Kanuma application is lengthy:  Kanuma received orphan product designation, received breakthrough therapy designation, was given priority review, and was granted a rare pediatric disease priority review voucher.

There is a lot to discuss about the Kanuma approval, and we will try to keep it high-level in the interest of our readers’ time. . .

You can read the entire post here.

FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents.

You can find the article here.

Patents4Life is Six Years Old this Month. Happy Birthday to Us!

Tuesday, March 3rd, 2015

OLYMPUS DIGITAL CAMERASix years ago, In re Kubin caused a flurry of concern among biotech practitioners, and a short article on this decision was the first post on Patents4Life. That was a pretty big “story” at the time but we all had no idea what was coming our way. It is difficult to think of an area of patent law that hasn’t been through a sea change since 2009, or at least has not encountered some very high seas.

There are not enough hours in today to do even a cursory review of the “State of Patent Law” since Patents4Life was started. Of course, one of the hottest topics right now is the scope of s. 101, and its breadth will surely be adjusted as the precedent piles up. And just consider, all of this debate is completely outside of the changes wrought in 35 USC by the AIA, the rise of generic biologicals that was set off by the ACA (“Obamacase”) and the Therasense, Teva v. Sandoz and Nautilus decisions.

(more…)