JTM Rapid Boards: Fwd: CDER New June 23, 2014

Monday, June 23, 2014

Fwd: CDER New June 23, 2014

---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jun 23, 2014 at 7:33 AM
Subject: CDER New June 23, 2014
To: iammejtm@gmail.com

What's New on the FDA Drugs Site

June 20, 2014

Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
FDA and Marijuana
- FDA and Marijuana: Questions and Answers
- Marijuana Research with Human Subjects
FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment
FDA Drug Shortages: New and Updated
- New Drug Shortage: Indigo Carmine Injection
From a Clinical Perspective: FDA actions reduce drug shortages but critical issues remain
National Drug Code Directory

New and Generic Drug Approvals

June 19, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Androderm	testosterone	Film, Extended Release;Transdermal	Watson Labs	Labeling Revision
Androgel	testosterone	Gel, Metered;Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel;Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel, Metered;Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel;Transdermal	Abbvie	Labeling Revision
Aveed	testosterone undecanoate	Injectable;Intramuscular	Endo Pharms Inc	Labeling Revision
Axiron	testosterone	Solution, Metered;Transdermal	Eli Lilly and Co	Labeling Revision
Bromfenac Sodium	bromfenac sodium	Solution/Drops;Ophthalmic	Apotex Inc	Approval
Combivent Respimat	albuterol sulfate; ipratropium bromide	Spray, Metered;Inhalation	Boehringer Ingelheim	Manufacturing Change or Addition
Delatestryl	testosterone enanthate	Injectable;Injection	Endo Pharms	Labeling Revision
Delsym	dextromethorphan polistirex	Suspension, Extended Release;Oral	Reckitt Benckiser	Labeling Revision
Depacon	valproate sodium	Injectable;Injection	Abbvie	Labeling Revision
Depakene	valproic acid	Capsule;Oral	Abbvie	Labeling Revision
Depakene	valproic acid	Syrup;Oral	Abbvie	Labeling Revision
Depakote	divalproex sodium	Tablet, Delayed Release;Oral	Abbvie	Labeling Revision
Depakote	divalproex sodium	Capsule, Delayed Rel Pellets;Oral	Abbvie	Labeling Revision
Depakote Er	divalproex sodium	Tablet, Extended Release;Oral	Abbvie	Labeling Revision
Fallback Solo	levonorgestrel	Tablet;Oral	Lupin Ltd	Approval
Fortesta	testosterone	Gel, Metered;Transdermal	Endo Pharms	Labeling Revision
Omnipaque 140	iohexol	Injectable;Injection	Ge Healthcare	Manufacturing Change or Addition
Omnipaque 180	iohexol	Solution;Injection, Oral, Rectal	Ge Healthcare	Manufacturing Change or Addition
Omnipaque 210	iohexol	Injectable;Injection	Ge Healthcare	Manufacturing Change or Addition
Omnipaque 240	iohexol	Solution;Injection, Oral, Rectal	Ge Healthcare	Manufacturing Change or Addition
Omnipaque 300	iohexol	Solution;Injection, Oral, Rectal	Ge Healthcare	Manufacturing Change or Addition
Omnipaque 350	iohexol	Solution;Injection, Oral	Ge Healthcare	Manufacturing Change or Addition
Omnipaque 70	iohexol	Solution;Urethral	Ge Healthcare	Manufacturing Change or Addition
Striant	testosterone	Tablet, Extended Release;Buccal	Auxilium Pharms Llc	Labeling Revision
Testim	testosterone	Gel;Transdermal	Auxilium Pharms	Labeling Revision
Testosterone	testosterone	Gel;Transdermal	Teva Pharms	Labeling Revision
Testosterone	testosterone	Gel, Metered;Transdermal	Perrigo Israel	Labeling Revision
Testosterone	testosterone	Gel;Transdermal	Perrigo Israel	Labeling Revision
Thalomid	thalidomide	Capsule;Oral	Celgene	Labeling Revision

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This email was sent to iammejtm@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

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Jeremy Tobias Matthews

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Custom Quality Promise

Riding Of The Practical Knowledge Through The Moves Done Up Ahead; Up River In The Visualization Of River Boarder Moves Being Done. One Should Fit The Shape That's Going To Steer Through The Rapids Accurately In Order To Make The Sport Safer And Better. It Is True That This Sport Is Beyond All Of Us Inspiring All Of Us River Boarders To Champion The Charge Up River In The Uplifting Of The Human Spirit, Therefore To Instance Such Self Reliance In Action By Shaping And Self Propelling In Roaring Rapids That Are Deep Enough Where The Rider's Wise Enough To Navigate With Some Custom Steering Edges By A River Boarder Capable Of Eyeing The Spot To Ride In. The Set Up Should Also Be Customized For Each Spot The Rider Is Going To Ride In. Any One Size Fits All Is Inaccurate When Dealing With Multiple Gaps Of A Set Of Rapids With Skimming Spaces On Either Side Wherefore Knowing Where All Of The Rocks Are At Is As Important As Is Where To Mix And Match The Handle System, The Board And Set Up To Fit What Gap In The Rapids You Want To Start From In The Ride Up River. All Shapes Are Available In Foam Composite Or Wood, Just Tell Me Which Shape As Well As Color Of Edges, Background, What Creature and Color Of It.

Thank You.

Safety Guidelines And Liability Release

1. Do Not Attach Rope Or Board To Yourself

2. Do Not Attach Metal To Board Or Set Up

3. Be Alert And Give Right Of Way To River Traffic

4. Do Not Leave Board Unattended In Water

5. Do Not Detach Set Up From Shore With Board In Water

6. Do Not Attach Set Up To Branches Of Trees

JTM RAPID BOARDS Warrants That They Are Not Liable And May Not Be Sued Against The Law For Personal Injury Caused By The Misrepresentation Of The Abilities To Have What It Takes To Handle This Sport, Nor Will They Be Blamed For Any Environmental Damages An Inexperienced Rider May Cause To His Or Her Own Board Or Set Up.

Knowledge Empowerment And Coaching

Here's What We Are Talking Here As Far One On One Lessons Being Procured For Sound Judgement Of River Safety And High End Athletic Display To Get To A Professional Level Of River Boarding Where The Rider Is Doing, An Actual Repertoire Of River Boarder Moves. It Is Fully Understood That Not Everyone Grew Up Swimming In A River And Is Prepared For Anything That Can Happen On One, That's Why We Have JTM A.K.A Jeremy Tobias Matthews River Boards. A Subsidiary Of River Ruler Entertainment. A Film And Music Production Label. Wether I Am Training You To Be A Future Franchise Owner Or Just So You Can Teach Your Own Children The Rate Is $90 An Hour Happy To Be Of Service Just Set An Appointment If You Need Me. See Also River Board Group Rate Lessons In The Search Box To To See Group Rate Lessons Before Setting An Appointment.

Thank You.

Quality And Service

The Soul Of The Sport Of River Boarding Is Connecting To The Specific Rapids We Ride In Through Working With Our Hands And Our Feet And So Moving To Moving Through With The Follow Through JTM Rapid Boards Hereby Discloses That Upon Receiving An Email Request For Order Form And Going Through The Email Exchange Estimate Process The Following Will Occur: The Rider Will Get The Exact Custom Board Made By Hand That They Want Within Two Weeks After We Have Received A Check Made Out To The Shaper By Hand To Jeremy Matthews(See Contact Info).

Thank You.

Stretch Technician Services

The Art Of The Stretch System Is To Get The Stretch The Same Consistency As The Current To Ride In So The Rider Is In Balance With The River. This Is A Lot Less Strain On The Body. It Also Makes For A Smooth Even Pull Up River With No Jerks Or Sudden Stops. Since Every Riding Spot Is Different The Professional Rider Has Different Length Segments To Match Different Spots. Therefore For The Safety Of Customers The Rider Should Know How Many Gaps They Want To Charge Up Into And How Deep The Water Is. The Shop Rate For Making A Set Up Is $40 An Hour Tie Off Instructions Included With Purchase. Please Set An Appointment For Estimate.

A3 Description

A4 Description

Overall This One Is Shaped Like An Otter However This One Does Have A Tendency To Get Caught In A Dive If The Rider's Weight Is Not Kept On The Back End To Prevent The Current From Taking The Nose To The Bottom So The Rider Must Adjust When Caught In a Dive. Don't Just Let It Go. You Will Just Have To swim To The bottom To Get It Anyway. You Might As Well Adjust Right Then And There And Put Weight On The Back End Of The Board While Your Exploring Underneath The River. It Does Have A Split Tail On The Rear Which Makes For Nice Rail To Rail Banking. It Also Has The Inverted Center So You Can Carry It Under Your Arm Like A SurfBoard With The Same Length As A3.

A5 Description

One Of The Things I Love About This Shape Is The Diversity Of Tricks It Allows. A Skilled Rider Can Do Any Trick On Any Shape Granted, But Some Tricks As A Shaper Has A Certain Shape In Mind, Just Work Better For Those Tricks. That Is Why A Good Shaper Rides The Boards They Make And Visualizes The Moves They Will Do Within The Movement And Bodily Timing With The Rapids Before They Make The Shape They Ride And So This Is The One That This Rider Can Do The Most Tricks Under The Water, On The Water And Above The Water With To Begin With, And Then Once The Tricks Are Mastered They Can Be Done On Any Board. Some Boards Will Work Better For Different Body Types So Knowing Your Own Body Is The first Step And Knowing The Tricks And Spot Come Next. Trust Yourself You Will Always Do That The Best.

Monday, June 23, 2014

Fwd: CDER New June 23, 2014

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