Orphan Drugs
Suzanne M. Sensabaugh Orphan Drugs Download Lecture Slide 1 Now orphan drugs. Orphan drugs are a category or a mechanism to encourage and facilitate the development of drugs for rare diseases or conditions. Slide 3 Now, a rare disease or a condition is a disease or...
Speeding Access to Therapies
Suzanne M. Sensabaugh Speeding Access to Therapies Download Lecture Slide 1 FDA has taken steps towards making investigational drugs more widely available to severely ill patients as well as towards speeding the review and approval of NDAs and BLAs for these products....
Chemistry, Manufacturing & Controls (CMC)
Pediatric Drug Development
FDA is making biological products more easily distinguishable
The US Food and Drug Administration (FDA) recently released the final version of the guidance document about nonproprietary naming of biological products. This long awaited document applies to originator biological products, related biological products and biosimilars...
Lorem Ipsum: when, and when not to use it
It helps to outline the visual elements of a document or presentation, eg typography, font, or layout. Lorem ipsum is mostly a part of a Latin text by the classical author and philosopher Cicero. Its words and letters have been changed by addition or removal, so to...
Neque porro quisquam est qui dolorem ipsum quia dolor sit amet
Fusce pellentesque dolor et nisi blandit, eget ultricies turpis luctus. Ut ut lacinia elit. Etiam accumsan sit amet odio ut dapibus. Fusce porta suscipit magna, sit amet pretium ipsum suscipit varius. Aenean eu metus in risus molestie cursus eget ac lorem. Donec...
Where can I get some?
There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration in some form, by injected humour, or randomised words which don't look even slightly believable. If you are going to use a passage of Lorem Ipsum, you need to be...
Where does it come from?
Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more...
Why do we use it?
It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here',...