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FDA Law Blog | fdalawblog.net Reviews

https://fdalawblog.net

where experts go to learn about the FDA

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1

FDA Law Blog

http://www.fdalawblog.net/fda_law_blog_hyman_phelps

Hyman, Phelps and McNamara, P.C. Jeffrey N. Wasserstein. Kurt R. Karst. Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Subscribe in a reader. Big Molecule Watch Blog. Bloomberg BNA Health Care Blog. Drug and Device Law Blog. Harvard Law Bill of Health. Internet Drug News.com. August 24, 2016. Still Not Ready for Prime Time: DEA Denies Petitions to Reschedule Marijuana. By John A. Gilbert, Jr. Larry K. Houck. Aug 12, 2016) [hereinafter.

2

FDA Law Blog: FDA Guidance Regarding Nutrition Labeling Regulations for Small Amount of Nutrients and Dietary Ingredients

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/08/fda-guidance-regarding-nutrition-labeling-regulations-for-small-amount-of-nutrients-and-dietary-ingr.html

Hyman, Phelps and McNamara, P.C. Jeffrey N. Wasserstein. Kurt R. Karst. Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Subscribe in a reader. Big Molecule Watch Blog. Bloomberg BNA Health Care Blog. Drug and Device Law Blog. Harvard Law Bill of Health. Internet Drug News.com. Laquo; It’s Nomination Season for the Best Legal Blogs; FDA Law Blog Needs Your Support! House Bill Targets Teenage Dextromethorphan Abuse ». August 03, 2015.

3

FDA Law Blog: Combination Products Reform Bill Is A Good Start, But Its Provisions Need Strengthening

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/08/combination-products-reform-bill-is-a-good-start-but-its-provisions-need-strengthening.html

Hyman, Phelps and McNamara, P.C. Jeffrey N. Wasserstein. Kurt R. Karst. Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Subscribe in a reader. Big Molecule Watch Blog. Bloomberg BNA Health Care Blog. Drug and Device Law Blog. Harvard Law Bill of Health. Internet Drug News.com. Laquo; Long Awaited Medicaid Rebate Rule Under Review by OMB. FDA Finalizes Guidance on Use of Nanomaterials in Animal Feed ». August 06, 2015. Jeffrey N. Gibbs.

4

FDA Law Blog: PREVOR v. FDA: Round II in Court

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/08/prevor-v-fda-round-ii-in-court.html

Hyman, Phelps and McNamara, P.C. Jeffrey N. Wasserstein. Kurt R. Karst. Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Subscribe in a reader. Big Molecule Watch Blog. Bloomberg BNA Health Care Blog. Drug and Device Law Blog. Harvard Law Bill of Health. Internet Drug News.com. Laquo; FDA Announces Fiscal Year 2014 User Fee Rates; They’re Movin’ On Up! August 01, 2013. PREVOR v. FDA: Round II in Court. By Allyson B. Mullen. FDA Issues Cal...

5

FDA Law Blog: Health Care

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/health-care

Hyman, Phelps and McNamara, P.C. Jeffrey N. Wasserstein. Kurt R. Karst. Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Subscribe in a reader. Big Molecule Watch Blog. Bloomberg BNA Health Care Blog. Drug and Device Law Blog. Harvard Law Bill of Health. Internet Drug News.com. May 12, 2016. Texas Finalizes Repeal of Medicaid Price Reporting Requirement. By Alan M. Kirschenbaum. Last October we reported. Posted at 06:01 PM in Health Care.

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biotechtranslated | Some thoughts from a scientist who moved to the business side of biotech | Page 2

https://biotechtranslated.com/page/2

Some thoughts from a scientist who moved to the business side of biotech. Vivus’ new obesity drug: Will it get scooped by generics before it even hits the market? July 2, 2012. This past Wednesday, the FDA approved. So Arena looks like they have a real winner on their hands. The next obesity drug up for approval is Qnexa from Vivus. I’ve written about Qnexa in the past ( here. The clinical trial data for Qnexa is actually much more positive than that for Belviq. Almost 50% of patients taking Belviq.

biotechtranslated.com biotechtranslated.com

Strategy | biotechtranslated

https://biotechtranslated.com/category/strategy

Some thoughts from a scientist who moved to the business side of biotech. How the government makes healthcare more expensive by cutting costs. January 3, 2014. Increasing healthcare costs are one of the most important issues facing the United States today. Although the rate of increase has slowed down. Over the past few years, the amount of money spent on healthcare in the US has risen at an alarming rate. Lets focus on the treatment of cancer for a moment; the cause and effect should be clear. To reduce...

biotechtranslated.com biotechtranslated.com

The hygiene hypothesis goes on trial… | biotechtranslated

https://biotechtranslated.com/2011/07/30/the-hygiene-hypothesis-goes-on-trial

Some thoughts from a scientist who moved to the business side of biotech. Larr; A perfect example of regulatory risk…. It’s like watching 5 year olds play soccer. The hygiene hypothesis goes on trial…. July 30, 2011. If there is one thing that excites me about the biotech industry, it’s the possibility that everything that we think we know about how to treat a disease will get turned on its head. A great example of this is the Nobel Prize winning work by Barry Marshall and Robin Warren. On the role of.

biotechtranslated.com biotechtranslated.com

Big pharma’s “pay-to-delay” deals: Helping or hurting patients? | biotechtranslated

https://biotechtranslated.com/2013/02/04/big-pharmas-pay-to-delay-deals

Some thoughts from a scientist who moved to the business side of biotech. Larr; A setback for the hygiene hypothesis. Just how much profit is there in a new drug? Big pharma’s “pay-to-delay” deals: Helping or hurting patients? February 4, 2013. A few weeks ago it was announced. Banning the deals and the Supreme Court will soon decide if the deals are legal. You might be wondering what these “pay-to-delay” deals are exactly, so lets look at a hypothetical example:. Where thing get complicated is that gene...

biotechtranslated.com biotechtranslated.com

Science | biotechtranslated

https://biotechtranslated.com/category/science

Some thoughts from a scientist who moved to the business side of biotech. FDA dismisses study that shows generic drugs are lower quality than branded version. April 10, 2014. In this blog post I’m going to take a step away from the business side of the pharmaceutical industry and dive a little bit deeper in to the science. In March of last year, a paper. Paywall) and a poster. This is a important issue in the industry right now as several foreign generic manufacturers, such as Ranbaxy. Happens slowly&#46...

biotechtranslated.com biotechtranslated.com

General industry topics | biotechtranslated

https://biotechtranslated.com/category/general-industry-topics

Some thoughts from a scientist who moved to the business side of biotech. If we reduce wastage, drug prices won’t go down. May 30, 2016. Back in March, the NY Times. Published an article claiming that we lose $3 billion dollars each year because of the cancer drug that are wasted. The article was inspired by a paper. Going even further than that, Peter Bach, one of the authors of the paper, infers that drug companies are intentionally. Doing this to boost their profits! That’s quite an accusation. In rea...

biotechtranslated.com biotechtranslated.com

October | 2013 | biotechtranslated

https://biotechtranslated.com/2013/10

Some thoughts from a scientist who moved to the business side of biotech. A setback for the hygiene hypothesis. October 29, 2013. It’s always interesting when a clinical trial you’ve been watching reads out. One of the first posts. I wrote for this blog was about a clinical trial that Coronado Biosciences was running based on the hygiene hypothesis. The company was testing the efficacy of. Ova (pig whipworm eggs) in treating Crohn’s disease. Well, Coronado Biosciences just released. Ova in several other ...

biotechtranslated.com biotechtranslated.com

Mike Hamilton | biotechtranslated

https://biotechtranslated.com/author/biotechtranslated

Some thoughts from a scientist who moved to the business side of biotech. If we reduce wastage, drug prices won’t go down. May 30, 2016. Back in March, the NY Times. Published an article claiming that we lose $3 billion dollars each year because of the cancer drug that are wasted. The article was inspired by a paper. Going even further than that, Peter Bach, one of the authors of the paper, infers that drug companies are intentionally. Doing this to boost their profits! That’s quite an accusation. In rea...

mikehartcxo.wordpress.com mikehartcxo.wordpress.com

CXO Footnotes | Page 2

https://mikehartcxo.wordpress.com/page/2

Newer posts →. January 21, 2011. Due process is a fundamental component of our legal system as is the human right of innocence until proven guilty. But one would think that when there is irrefutable and undeniable evidence of the commission of a crime (like there is in the Giffords’ case) few legal options would be available to delay justice. Insanity? Most of us who blog. However, that don’t see the need for a filter and it works. They are the lucky ones. As part of the coverage of the U.S. visi...Yet, ...

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Food & Drug Law Course | SMU Law School, Fall 2010

Food and Drug Law Course. SMU Law School, Fall 2010. Not So Fast Pomegranate Juice. September 28, 2010 by Nathan Cortez. The FTC is in a kerfuffle with the manufacturer of Pom Wonderful. Additional readings for Tuesday September 21st. September 15, 2010 by Nathan Cortez. For the second class on dietary supplements on Tuesday, September 21st, please read the following documents about FDA’s objections to Del-Immune’s labeling. Read the web site that gave rise to FDA’s warnings. There is also a course reade...

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FDA Law Update Blog | Sheppard Mullin

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