Writing Resources
In December 2017 the FDA issued a draft guidance titled Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases This draft guidance pertains to the Orphan Drug Act was created by Congress in 1983 This act was authorized to encourage pharmaceutical companies to develop drugs for diseases that affect a small percentage of the population Koperniak 2017 To encourage companies to develop orphan drugs the Orphan Drug Act of 1983 included provisions designed to offset the cost of producing orphan drugs In order to qualify for Orphan Drug status a drug must be for a disease or condition with an overall prevalence of less than 200 000 people Historically the FDA allowed for drugs to receive the orphan drug designation for pediatric sub populations if the prevalence in pediatric patients was below 200 000 even if the disease is fairly common in adult populations U S Department 2017 This is became known as the pediatric subpopulation designation The FDA guidance issued in December 2017 uses the example of ulcerative colitis Ulcerative colitis is prevalent in adults however is drugs to treat ulcerative colitis have been granted pediatric subpopulation designation because in children the disease affects less than 200 000 patients The pediatric sub population designation was created to encourage the study of drugs in the pediatric population as typical clinical testing only involves adult populations Several programs have been created since the
You blink as if you can't quite believe what you're hearing Yes yes you re not imagining it I m speaking to you I suppose is how you would understand it B but you say out loud and a couple of the other specimens stare to look at you in confusion Now now There is no need to speak out loud I will be able to hear your thoughts Your kind comes along so rarely I would hate for you to get taken in to some prison and electrified Electrocuted actually you say this time in your head Then you shake your head as if you can t believe what you just said Wait I you Use your words now My mocking tone momentarily angers you clearing your thoughts Who no what are you you say again in your head Ah but you know already don t you You were just thinking about it You blink and frown I was thinking about something Your frown deepens I know what I was thinking about I am thinking about it right now and when I do everything sort of goes blurry and I feel like I'm watching myself in third person but I couldn't tell you what exactly I m thinking about Precisely My sudden excitement makes you jerk
