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No Prescription Needed?

No Prescription Needed? News & Analysis News From the Food and Drug Administration Paving the Way for Biosimilars nose, or treat illnesses linked with chemical, Department of Health and Human Services’ The FDA’s recently announced Biosimilars biological, radiological, and nuclear threats Biomedical Advanced Research and Devel- Action Plan will take steps to increase ac- as well as emerging infectious diseases. opment Authority. cess for patients who need biologic medica- tion to biosimilar drugs that are nearly iden- No Prescription Needed? tical to but potentially much less expensive The FDA has issued draft guidance outlin- than the original product. ing ways in which some prescription drugs In announcing the 11-point plan, FDA could be made available to consumers with- Commissioner Scott Gottlieb, MD, said the out a prescription. market for biosimilars still isn’t established FDA Commissioner Scott Gottlieb, MD, and their ability to penetrate clinical prac- said the agency’s “hope is that the steps tice still isn’t firm. “The policy and regula- we’retakingtoadvancethisnew,moremod- tory decisions that we make today are go- ern framework will contribute to lower costs ing to have a lot to do with whether we for our health care system overall and pro- realize the promise for this new category http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

No Prescription Needed?

JAMA , Volume 320 (7) – Aug 21, 2018

No Prescription Needed?

Abstract

News & Analysis News From the Food and Drug Administration Paving the Way for Biosimilars nose, or treat illnesses linked with chemical, Department of Health and Human Services’ The FDA’s recently announced Biosimilars biological, radiological, and nuclear threats Biomedical Advanced Research and Devel- Action Plan will take steps to increase ac- as well as emerging infectious diseases. opment Authority. cess for patients who need biologic medica- tion to biosimilar drugs that...
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Publisher
American Medical Association
Copyright
Copyright 2018 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2018.11596
Publisher site
See Article on Publisher Site

Abstract

News & Analysis News From the Food and Drug Administration Paving the Way for Biosimilars nose, or treat illnesses linked with chemical, Department of Health and Human Services’ The FDA’s recently announced Biosimilars biological, radiological, and nuclear threats Biomedical Advanced Research and Devel- Action Plan will take steps to increase ac- as well as emerging infectious diseases. opment Authority. cess for patients who need biologic medica- tion to biosimilar drugs that are nearly iden- No Prescription Needed? tical to but potentially much less expensive The FDA has issued draft guidance outlin- than the original product. ing ways in which some prescription drugs In announcing the 11-point plan, FDA could be made available to consumers with- Commissioner Scott Gottlieb, MD, said the out a prescription. market for biosimilars still isn’t established FDA Commissioner Scott Gottlieb, MD, and their ability to penetrate clinical prac- said the agency’s “hope is that the steps tice still isn’t firm. “The policy and regula- we’retakingtoadvancethisnew,moremod- tory decisions that we make today are go- ern framework will contribute to lower costs ing to have a lot to do with whether we for our health care system overall and pro- realize the promise for this new category

Journal

JAMAAmerican Medical Association

Published: Aug 21, 2018

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