FDA Launches Orange Book Mobile Application



FDA and CDER have launched a mobile application (app) to put timely information about generic drugs in the hands of those using smartphones and tablets. The new app makes it easy and convenient to view The Approved Drug Products with Therapeutic Equivalence Evaluations list. This list is most commonly known as the “Orange Book.”

The Orange Book Express mobile app provides users with a mobile-friendly way to identify drug products approved on the basis of safety and effectiveness by the Agency, as well as information about patents and exclusivity. It allows them to search both the Active Ingredient and Proprietary Name fields at once, without searching separately for each marketing status for prescription, over-the-counter, and discontinued products. Users can also search by patent number without specifying a marketing status. The app will differ from the full Web version of the Orange Book in that the ability to filter results and search for text within results will be unavailable via data download.

Orange Book users include pharmacists, prescribers, industry, Agency employees, and third-party payers. Industry personnel refer to the Orange Book for its patent pages and product-specific exclusivity information, and to determine reference standards or drugs for performing their bioequivalence studies. Third-party payers, pharmacists, and prescribers use the Orange Book to determine appropriate generic drug substitution.

The Orange Book first appeared as a print publication in October 1980. Today “Orange Book” is one of the most searched-for terms on FDA.gov.

The Orange Book Express mobile app reflects our commitment to keep up with the latest technologies, developing effective means for the public to access important and useful information about generic drugs. The app also makes the Orange Book available to a wider audience than ever before – supporting users who may not always have convenient access to a computer or wired Internet connection.

I would like to sincerely thank the Office of Generic Drugs and the Office of Communications for their innovative efforts to bring us to another significant milestone in generic drug history. As a result of their work, easy access to real-time information about generics is available. This is especially important for health care professionals who rely on this information in protecting their patients’ health and providing consumers with alternatives to brand name drugs.

For more information about the new mobile app, including links for free download via iTunes or Google Play Store, visit Orange Book.

Different companies have different release dates. They should by end of quarter (Dec 30), but no requirement to release a PR until then.

Another point of interest in the new PR, by keeping Dr Ichim on contract rather than him leaving all together or working reduced hours then hiring his replacement indicates the need for both indicating that there must be many things on the front burners that are timely as well as important going on now and the near future.

Not Bad news

2 for price of 1

Dr Lander in to continue on, Dr Ichim working as he sees fit while under treatment or recuperating.

If recuperation a success, expect him back

More shares are needed for the merger negotiations. Partner will pay for share package incentive

News out Australian patent

GC new tweets

FDA insider, nice

Coming to a theater near you this fall, Will Smith stars in a movie about sports concussion research called Concussion.

He plays a research dr looking into traumatic brain injuries in sports, sounds familiar for some reason,

Run Google search for info

New President = Pre FDA Approval Org Move

There might be a PR stating the results were submitted to the FDA, but for a PR on FDA news, i doubt if the FDA moves that quick to issue an approval right after the docs are submitted. It first has to make it out of the mail room into the first inbox, then another, then finally reviewed, then meetings to discuss the results, then a determination, then a few days to get that finalized and written and entered into their database, then notification.

guessing 2-3 more weeks at the quickest, month outside.

We're waiting with baited breath, the FDA isn't waiting for the safety tests, they have other things going on, when it arrives, it will be entered on their to do list

Disagree, just your paranoia setting in

Me thinks most confuse real solution with jittery novice day trader selling

That's why I bought more today

They didn't say they did so we have to go with that

They said they have the lab reports, which mean the have to write up answers to FDA q's using the data showing proof of safety.

They just font open an envelope and forward it.

So I guess the class action suits are off the table, along with incessant name calling and hissy fits, or at least until two weeks from now when there is no PR, then the crying game starts up again

But you all still come back day after day

telling...

I sense a Chairmanship Blog soon

Someone spend $50 and get this up 8% EOD

That sticky (above) is so old and outdated, it turned yellow

The PR before last stated they were expecting FDA approval in Sept, loading time

With big boards crashing, this might hit gold when FDA releases announcement and other investors jump in to recoup big board losses, more so than before.

Good PR, Patent protects AMBS. Only the ignorant don't understand the future value.

Overkill dude
Take your mess and ride your skateboard

I stopped reading at "eny".

New job more money, maybe has to move

Why blame GC when the people on this board are selling

Bought a few thousand today.nice price range

Just remember, you can't bring your skateboards inside, have your moms hold them for you on the sidewalk. Bring extra cookies so you don't get cranky through the long day.

Why hasn't the news been updated above

MANF-CDNF Protein Symposium
Register
First MANF & CDNF Proteins Symposium
Two-Day International Symposium
San Francisco, CA
September 14 -15, 2015


http://manfandcdnfsymposium.com/


from Dr. Urano

Symposium Highlights

Conserved in Evolution from C. elegans to Man
Endoplasmic Reticulum Stress Response Proteins
3-D Structures & Domains: Adrian Goldman, Univ Leeds
Protection in the ischemic heart: Christopher Glembotski, UCSD
Secretion, binding and KDEL receptors: Brandon Harvey, NIH/NIDA/IRP
Wolfram Syndrome/ER Stress: Fumihiko Urano, Wash Univ Sch Med
Cellular Proteomics: Sean Bendall, Stanford Univ
Diabetes: Maria Lindahl, Univ Helsinki
Inflammation: Yuxian Shen, Anhui Med Univ
Animal models of neurodeg diseases: Mart Saarma, Univ Helsinki
Discovery of MANF: John Commissiong, Amarantus Biosci
Drosophila genomics: Tapio Heino, Univ Helsinki
Zebrafish developmental biology: Pertti Panula, Univ Helsinki


SESSION I
Discovery of MANF & CDNF and Their Roles in Neurodegenerative Diseases
Chair: John Commissiong
8:00 - 10:40
8:00 Introduction and Welcome
8:10 Discovery of MANF: From biological activity to recombinant protein, and the promise of biologics
John Commissiong, Amarantus Bioscience, Inc.
8:50 Discussion
9:00 Discovery of CDNF: Animal models of neurodegenerative diseases
Mart Saarma, University of Helsinki
9:40 Discussion
9:50 Impaired expression of MANF in mice leads to cerebellar Purkinje cell degeneration
Xiao Li, Emory University School of Medicine
10:30 Discussion
10:40 Coffee break
SESSION II
Short Oral Presentations
Theme: Neurodegeneration
Chair: Päivi Lindholm
11:00 - 12:00 noon
11:00 Short oral presentation: #1
11:12 Short oral presentation: #2
11:24 Short oral presentation: #3
11:36 Short oral presentation: #4
11:48 Short oral presentation: #5
Abstracts for the short oral presentations will be selected by the Program Committee.
Postdoctoral candidates and graduate students are encouraged to submit abstracts.
Airfare & hotel will be paid for the first author of the three best oral abstracts.
Monday Afternoon, September 14

SESSION III
Poster Session: All 25 posters will be on display
Posters # 1-15 will be manned
Theme: Neurodegeneration
Airfare and hotel will be paid for the first author of the three best poster abstracts
12:00 - 2:00
Lunch: 12:00 - 1:00
SESSION IV
Endoplasmic Reticulum Functions, Binding Proteins and Secretion
Chair: Mart Saarma
2:00 - 3:40
2:00
MANF, a secreted sarco/endoplasmic reticulum protein in cardiac myocytes with protective functions in the ischemic heart
Christopher Glembotski, SDSU Heart Institute
2:40 Discussion
2:50 Modulation of MANF secretion and binding by KDEL receptors
Brandon Harvey, NIH/NIDA/IRP, Baltimore, MD
3:30 Discussion
3:40 Coffee break
SESSION V
Drosophila Genomics and Zebrafish Developmental Biology
Chair: Pertti Panula
4:00 - 5:40
4:00 In vivo studies on the Drosophila ortholog of MANF
Tapio Heino, University of Helsinki
4:40 Discussion
4:50 Zebrafish MANF: Regulation of dopaminergic neuronal development
Pertti Panula, University of Helsinki
5:30 Discussion
5:40 Informal Wine & Cheese
Tuesday Morning, September 15

SESSION VI
3D Structure of MANF & CDNF and their roles in endoplasmic reticulum function
Chair: Brandon Harvey
8:00 - 10:30
8:00 3-D Structure of MANF and CDNF: Domains and functional implications
Adrian Goldman, University of Leeds
8:40 Discussion
8:50 MANF-based therapy for Wolfram syndrome, a prototype for ER stress induced diabetes and neurodegeneration
Fumihiko Urano, Wash University School of Medicine, St. Louis, MO
9:30 Discussion
9:40 MANF Is essential for the proliferation and survival of pancreatic ß-cells
Maria Lindahl, University of Helsinki
10:20 Discussion
10:30 Coffee break
SESSION VII
Short Oral Presentations
Theme: Endoplasmic Reticulum Biology
Chair: Larry Schwartz
11:00 - 12:00 noon
11:00 Short oral presentation: #6
11:12 Short oral presentation: #7
11:24 Short oral presentation: #8
11:36 Short oral presentation: #9
11:48 Short oral presentation: #10
Abstracts for the short oral presentations will be selected by the Program Committee.
Postdoctoral candidates and graduate students are encouraged to submit abstracts.
Airfare & hotel will be paid for the first author of the three best oral abstracts.
Tuesday Afternoon, September 15

SESSION VIII
Poster Session
All 25 posters will be on display
Posters # 16-25 will be manned
Theme: Endoplasmic Reticulum Biology
Airfare and hotel will be paid for the first author of the three best poster abstracts
12:00 - 2:00
Lunch: 12:00 - 1:00
SESSION IX
Inflammation, Neurodegeneration and Biology
Chair: Fumihiko Urano
2:00 - 4:30
2:00
The role of MANF in inflammation
Yuxian Shen, Anhui Medical University, CN
2:40 Discussion
2:50
Immune modulation by MANF promotes tissue repair and regeneration in the retina
Joana Neves, Buck Institute for Aging
3:30 Discussion
3:40 Expression of MANF and CDNF and the search for their interacting proteins
Päivi Lindholm, University of Helsinki
4:20 Discussion
4:30 Coffee break
SESSION X
Special Lecture
Neurotrophic factors: Challenges in their clinical development
Steven Gill, Frenchay Hospital, University of Bristol
Chair: Adrian Goldman
4:45 – 5:30
5:30 Discussion
5:45 Closing remarks
6:00 Cocktails
6:30 Conference Dinner

Maybe he has some data, and knew fully well that he had to uplist to get to Nasdaq so he can release the news timely, no matter what the present pps was at the time of the R/S; knowing that the news would spike the pps.

Time to dry your eyes and open them a little.

There is a lot of stupid in the air lately

Pathetic whiners


Companies don't issue major headline every day or week, the few of you that have a real job or career know this, but those who sit all day on the computer posting inane crybaby statements know very little and show it repeatedly.

Hated by...you

Watch next week for news

Here comes the iceberg

I'm building a solid foundation

picking up a chunk at EOD

have a good weekend all