Drug Development Process – From Discovery to Marketing

Overview: This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. […]

200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved […]

Breast cancer warning from man stunned by ‘impossible’ diagnosis

When you think of breast cancer, you think of a form of cancer that affects only women. It doesn’t. While breast cancer in men is rare it’s still an issue for the 10 men on average who are diagnosed with it every year in Northern Ireland. Ian Cranston, 70, was diagnosed with breast cancer in […]

MS could be reversed with existing allergy drug

In a recent phase II clinical trial, an over-the-counter allergy drug was shown to improve nervous system function in patients with multiple sclerosis. Multiple sclerosis (MS) is an autoimmune disease affecting more than 2.3 million people around the world. The condition attacks myelin, or the waxy coat around nerves, and compromises the nerves’ ability to transmit messages. Over time, as […]

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions. Walgreens, Rite Aid and CVS Health stocks each slipped 4 percent or more as investors worried Amazon may disrupt the traditional distributors’ hold on the drug prescription market. Amazon will […]

Are any weight loss supplements considered safe?

Every year, millions of Americans go after this same goal, some successful and others not so much. To attain their goals, they may choose from the over-abundance of diets and exercise programs available, and some turn to weight loss supplements as well. While you shouldn’t rely on supplements to do all the work for you, […]

Depression: Is brain inflammation tied to suicidal thoughts?

A new study confirms the link between inflammation of the brain and the prevalence of suicidal thoughts in people diagnosed with major depression. This is the first study of its kind to measure relevant biomarkers in living individuals. Major depression is a very common mental condition, with 6.7 percent of all adults in the United […]

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

The FDA’s requirements for Drug Applications and Submissions

The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions. The NDA process […]