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Astellas Pharma Named National Presenting Sponsor for National Kidney Foundation Walk

The National Kidney Foundation has announced that Astellas Pharma US, Inc. was named the first-ever National Presenting Sponsor for the Kidney Walk. 

USHCC Welcomes Boehringer Ingelheim as New Strategic Partner

Boehringer Ingelheim's commitment to educating the Hispanic community on the impact of chronic disease is particularly noteworthy. 

Praxair Recognized for Environmental, Social and Governance Excellence

Praxair, Inc. announced it’s been listed on the STOXX Global ESG Leaders Index and STOXX North America ESG Leaders 50 for the third consecutive year. 

12 Yr Old Girl Battles Brain Tumor, Family Petitions FDA

A fast-growing petition is asking the FDA to grant 12 year old McKenzie Lowe of New Hampshire with “compassionate use” access to Antineoplastons therapy, a treatment that could save McKenzie from her inoperable brain tumor (DIPG).

Long Live the Revolution! Goodbye and May 2013 Be Filled With Positive Change for All of You

I apologize if some of my columns over the years have seemed a bit negative or critical.  As a publication, we started up at a time when thought leaders pointed out the seemingly limitless potential to improve and modernize manufacturing.  

Building a Culture of Quality and Compliance: Are 483's Just Part of Doing Business?

Pop quiz!  Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))Contamination during the manufacture of serum injectables?Failure to measure or account for endotoxins?  Failure to respond to adverse patient reactions?  Presence of vermin and unsanitary conditions at the...

Criticizing the Cynicism Behind the Current Compounding Scandal

We wanted to criticize, in as forceful and graphic a way as possible, the cynical attitude of the compounding facility management, to call attention to the disgraceful conditions that were found at many of the compounding facilities that were inspected, and also to draw some attention to the political situation (e.g.

Changes to Come at CDER: A Letter From Janet Woodcock

Just received confirmation of last post.  Here's the official letter announcing changes from CDER Director, Dr. Janet Woodcock

FDA to Give Generics More Prominence: Rumors of Change

Haven't confirmed any of this yet, but just heard rumors of change, and another 'superoffice' restructuring at FDA. Apparently, within the new framework, the Office of Generic Drugs will become a "superoffice", OPS will be no more, while OMPQ, ONDQA and OBP will report to OPQ.  The Office of Compliance...