I think I would want to work for the sponsor company as the person putting the clinical protocols together. It seems like it would be an interesting position where not only would I get to prepare proc...

Right to try law allows terminally ill patients to have access to drugs that are not yet approved by the FDA. If all other treatments have been attempted and resulted in failure and there is a high ch...

Clinical studies do come with risks but they are an important part of drug and medical device development processes. After getting favorable results from pre-clinical trials, companies need to further...

Marketing is the activity of promoting, distributing and selling your product to a customer. It takes a good communicator to convince people into buying your products over others'. I think the whole m...

I think the way it works is that the companies have certain employees that they send out to conferences where they give presentations to physicians who might be interested in their products. Another w...

I am choosing J&J to do a SWOT analysis. Strengths They provide to three different segments: consumer products, pharmaceuticals and medical devices. This helps them have a higher presence in the ...

Yes, I would definitely consider doing a partnership in the future. Partnerships are a great way to do business when you have family members or friends that you want to work with. It comes with many b...

One major difference between publicly and privately held companies is the way they deal with public disclosure. A public company has to reveal everything quarterly and annually to the SEC who reviews ...

If I was to have ownership of a business, I would most likely choose to go with the limited liability company option. This form of business allows the owners or partners to minimize their personal lia...

Dr. Simon mentioned in this week's lecture that FDA can issue Form 483 to a company if its practices are not in compliance with the rules and regulations set by them. He gave the analogy that having F...

I think every department needs to understand the importance of their individual roles. R&D shouldn't blindly rely on the quality department to make sure the products they developed are safe. Quali...

In my opinion quality control is an integral part of any company and is worth every single dollar spent on it. Companies serve to customers who have specific needs and it is the quality engineers' res...

It might be a lot of work on the companies' end because of all the regulatory steps they need to follow to bring a product to the market. It seems to be tedious work but these products are used on or ...

Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. ...

An antibiotic-releasing hip stem is a combination product. If I was the regulatory person working with this product, the first thing I do would be to submit a request for designation to the office of ...