Axiona Solutions

02/11/2018

Keep Xylitol Away from Dogs

12/01/2017

Risk-Based Approaches To Establishing Sample Sizes For Process Validation

The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the ...

30/06/2016

Here Is Something to Chew On ... Quality Attribute Considerations for Chewable Tablets

Here Is Something to Chew On By Bob Po***ck | June 19, 2016 | FDA, Generics, Regulatory Affairs | 2 | Ever had a tablet that was too big and you wished you could chew it? Well, some immediate-release tablets are designed to be chewable and carry such designation. The Guidance, titled “Quality Attr...

30/06/2016

A good news for the patients with presbyopia...

The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near visi...

18/03/2016

Make sure the quality of your future eCTD ANDAs to avert a possible loss of any GDUFA goal date

Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet? By Bob Po***ck | March 14, 2016 | FDA, Generics, Regulatory Affairs | 3 | The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Res…

01/03/2016

World’s 10 Best Pharma and Biotech Companies of 2015

With $16.3 billion in profits, $131 billion in assets, and $276 billion in market value, Johnson & Johnson takes the crown as the world’s largest drug and biotech company again this year, edgin…

05/11/2015

Forging the Path Forward toward Global Food Safety

Forging the Path Forward toward Global Food Safety Posted on November 3, 2015 by FDA Voice By: Camille Brewer, M.S., R.D., Donald Prater, D.V.M., and Leigh Verbois, Ph.D. Camille Brewer, M.S., R.D., Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine. These are excitin…

15/01/2015

FDA approves first-of-kind device to treat obesity. http://go.usa.gov/zEJm

The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.

05/12/2014

FDA approved ruxolitinib (Jakafi, Incyte Corporation) for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU). December 4, 2014. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425732.htm

05/12/2014

The guidance describes how a prospective ANDA applicant can obtain a letter stating that FDA has determined:

- prospective ANDA applicant’s bioequivalence study protocol contains safety protections comparable to those in the REMS for the reference listed drug, and

- FDA will not consider it a violation of the REMS for the reference listed drug holder to provide a sufficient quantity of the reference listed drug to the prospective ANDA sponsor or its agent to allow the company to perform the testing necessary to support its ANDA.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425662.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

04/12/2014

FDA granted accelerated approval for blinatumomab (BLINCYTO, Amgen Inc.) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL). December 3, 2014 . More Information:
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425597.htm