The first electronic cigarette was patented and marketed in 2004. Since then, e-cigarette use has grown exponentially across the globe. And the use of vaping devices comes with a lot of policies and regulations. The consequences of vaping on health…   Read more»

Regulatory affairs experts are involved in all phases of development, and even after drug approval and commercialization. They have a unique mix of both scientific and management skills to reach a commercially important goal within a drug development organization. The…   Read more»

The U.S. FDA has the job of preserving the public health of all U.S. consumers through the regulation of a potential health risks; which includes human and veterinary drugs, biological products, medical devices, food, cosmetics, and products that put out…   Read more»

I too used to take Accutane. I was lucky and received none of the side affects.  The FDA cant guarantee safety ever.  I feel when you are using products for such a variety of things and for a variety of…   Read more»

One role in quality management is a Quality Assurance (QA) Specialist. A QA Specialist is responsible for ensuring that products or services meet established quality standards and requirements. They work to identify and prevent quality issues, and ensure that corrective…   Read more»

[quote data-userid=”21147″ data-postid=”17321″] Since we’re are about halfway through the semester I was wondering what part of a project may you find the most difficult? Personally I feel that budgeting and providing positive clinical studies may be the most difficult….   Read more»

One challenge project managers face when handling a project is managing scope creep, which is the tendency…   Read more»

Dealing with project failure is…   Read more»

I don’t think the FDA guarantees safety, however, I do believe that the organization tries its best to ensure safety. With both FDA-approved and Non-FDA improved, one should use their best judgement. Our bodies are different, we react differently to…   Read more»

I am currently working at a cell and gene therapy company. Recently, there was an incident that resulted in failure of a process and sterility tests. After doing a root cause analysis, upper management determined that Quality Assurance needed to…   Read more»

I agree with most of the posts on this specific topic, the FDA is well within reason for their guidelines because, while there are other organizations that protect public safety. There are many necessary things that the FDA ensures for…   Read more»

MDSAP stands for the Medical Device Single Audit Program and it is for the conduct of a single regulatory audit of a medical device manufacturer’s QMS that satisfies the requirements of multiple regulatory jurisdictions. The dialogue in this post has…   Read more»

I think the FDA does guarantee safety of the products in which they approve. Yes, there are an endless list of side effects when it comes to most prescription drugs, but I think the word safety, as described by the…   Read more»

I haven’t worked in either quality control or quality assurance. But I have thought of this question before because I do work in R&D and I have always wondered how the Quality department makes sure that everything we’ve tested pasts…   Read more»

I do not think that everything that causes a recall I because of the FDA. Things such as sterilization comes from responsibility of the company. It is up to the company to make sure the things that they manufacture and…   Read more»

Great question. I do not believe that all FDA approved products are guaranteed safe. One Everyone’s body reacts differently to a drug. Some people may react perfectly fine to a drug while others may have serious side effects. The FDA…   Read more»

I am currently a Quality Systems Technician at Theragenics. They also call us QAs. Theragenics is a corporation that manufactures and distributes medical and surgical equipment for brachytherapy. We verify a lot of things within the operation to make sure…   Read more»

The FDA (U.S. Food and Drug Administration) is responsible for regulating and ensuring the safety and efficacy of food, drugs, and medical devices in the United States. However, while the FDA plays a crucial role in regulating products, it cannot…   Read more»