EMA Updates Inspector Expectations for API Audits

EMA Updates Inspector Expectations for API Audits

As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.

Eisai Announces Availability of BELVIQ® (lorcaserin HCl) CIV Tablets for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese BELVIQ Available in U.S. Pharmacies within One Week

New Drug Approvals


june 7, 2013 –Eisai Inc. announced today that BELVIQ (pronounced BEL-VEEK) will be available to eligible patients by prescription in the United States beginning June 11.


BELVIQ was approved by the U.S. Food and Drug Administration on June 27, 2012 to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes.  It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes your risk of heart problems or stroke, or of death due to heart problems or stroke.


“BELVIQ is a new treatment option…

View original post 498 more words

Curriculum Vitaes in Training Records

Inspired Pharma Blog

I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records.  This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.CV1

View original post 656 more words

Should You be Taking Supplements?

Long Live Food- Holistic Health Counseling

I get asked this all the time, “what do you think about supplements?”  While there is much debate about whether or not vitamins and minerals are necessary to take in a daily pill form, some people approach supplementing with the thought, “well, it can’t hurt!” Image

The thing is, unfortunately there are many not-so-great brands of vitamins and minerals.  What makes them bad?  Well for one, they can be contaminated, and two, the forms of minerals can be hard to digest and absorb, making some supplements a complete rip off.

However, even if you are eating fruits and veggies each day, you are most likely missing out on some major vitamins and minerals for your body. Thus, supplementing can help you catch up on some important vitamin and mineral deficiencies.

Many health counselors, like me, often recommend the following supplements:

  • A fish oil, krill oil, or flaxseed oil:…

View original post 281 more words