All Blog Posts (1,642)

A few skills need to be imbibed by professionals, even if they are out of their domains or area of expertise. This is because when it comes to handling crunch situations; one cannot expect a manager to…

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial.

The results were part of a recent update that Vertex…

  What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new…

The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.

The Quality…

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was…

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of…

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set…

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for…

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.

He is the second person to die from…

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.

The research,…

As Republicans struggle to score a legislative win on taxes, Steve Forbes dismissed fears that the American economy is doomed to slow economic growth or secular stagnation as “preposterous.”

Forbes, the chairman and editor-in-chief of Forbes Media and former Republican presidential candidate, blamed the current economic rut on correctable policy errors in a lecture sponsored by the Cornell Republicans on Wednesday.

The real source of…