Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

PurposeThe Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access.MethodsFDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared.ResultsThe FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight.ConclusionThe FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/115991/1/cts12255.pd

Quiet time observations of the open‐closed boundary prior to the CIR‐induced storm of 9 August 2008

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/95511/1/swe467.pd

Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/115990/1/cts12315.pd

The Ursinus Weekly, February 26, 1976

WRUC is on the air • Dr. Parsons tells of visit to Germany • Election results • Student interns join WPAZ radio staff • Student-Board Comm. meets • Loyalty fund is thriving • Spiropoulos examines J.F.K. assassination • Free Library • Editorial: Food for thought or? • U.C. speakers • Editorial: Energy woes are for real and jobs are at stake • Careers vs. liberal arts • Viewpoint: Mr. Bloom\u27s point is worth repeating • Bearpit action • Seminars for women offered: Women and the law; Women and finance • JV Bears play .500 • Bears do swim! • Our bouncing Bears • Focus: Greg Thren • Spring feverhttps://digitalcommons.ursinus.edu/weekly/1052/thumbnail.jp

The Ursinus Weekly, October 21, 1977

Ursinus news in brief: Espada speaks at conference; Ursinus Homecoming; Buy a slave! • Craft elected as officer • New dining style proves popular • Board to vote on calendar • Students experience new dining style • Student employment remains stable • Comment: Student involvement; On cocktail grading • Letters to the editor • 1.2 million raised: Advance Ursinus first year • The Power behind Ursinus mediocrity • Homecoming candidates • Ursinus and the first digital computer • Bears finally come out of the woods • Varsity & JV hockey • C.C. 7-1! • 3 & 4: All wins • Volleyball: Dig it! • Bears winhttps://digitalcommons.ursinus.edu/weekly/1073/thumbnail.jp

The Ursinus Weekly, November 20, 1975

Sub-stantial lunch presented by Union • Dorm visitation reform urged • The Party\u27s over • Explosive evidence • Student letter sent to Board • New Student Affairs subcommittee formed • Editorial: Communication before tragedy • Letters to the editor: Reactions • Grad. School crunch etc. • ProTheatre puts best foot forward • Coffeehouse reviewed • State of the Union • New service at Myrin • Forum review: Lindsay on energy • Photo exhibit opens • 1-6-1 And something must be done! • Ursinus\u27 women\u27s hockey starlets repeat success! • Wrestler\u27s preview • Manning\u27s men • C. C. team • NBA preview part IIhttps://digitalcommons.ursinus.edu/weekly/1047/thumbnail.jp

The Ursinus Weekly, October 2, 1975

Meetings on Perkiomen Valley growth • In memoriam • Gene Shue presents: Year of the Sixers • City planner speaks • Ursinus College appoints Assoc. Prof. of Education • Kane earns Doctorate • Editorial: A different year? • Is there more to life? • New dorms renovated • Saturday Lunch • Forum series opens: Nina Deutsch • Musical notes • Chris Hillman rated • New events at Walnut • Nancy Drew revisited • Alumnus is named to Library post • British history specialist joins Ursinus faculty • Instructor returns to Ursinus • Pa. Dutch Program is success • Instructor appointed to Biology Dept. • Lindback Award presented • Soccer season opens • Ursinus allies with area • Balloons! • Ursinus named a \u2776er • Register now! • Grads elect officers • Yes we can gang didn\u27t • NFC forecast • MAC report • F & M stings Bears 35 - 21https://digitalcommons.ursinus.edu/weekly/1041/thumbnail.jp

The Case of the Curious Robot: On the Viability of Curious Behavior in Robots

Curiosity is a core drive for learning in humans which is increasingly being looked at in developing robots capable of internally motivated lifelong learning. However, there are also potential risks associated with robots being curious when people do not expect or want robots to be curious, especially when the robot already has work tasks to perform. Further, how robots’ mental states are described may prime expectations inhuman counterparts. This thesis presents a pair of experiments on people’s perceptions of four levels of curious robot behavior, designed by a professional animator. We also explored the impacts of a curious robot being seen as on-duty vs. off-duty. In addition,we examined whether our curious robot behavior matched peoples’ expectations when primed to expect a “curious” vs. “learning” vs. “autonomous” robot. In both studies, as curious behavior increased so to did ratings of the robots’ thinking ability coupled with a decrease in ratings of it as an effective working and social agent, particularly when it was framed as on-duty. Further, each cognitive prime resulted in a unique trajectory of expectation matching showing that robots’ internal mental states should be matched with analogous external behaviors. Our findings have implications for the design and development of robots that engage in learning modeled on human cognition