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Promoting Patient Interests in Implementing the Federal Right to Try Act.
Lynch HF, Zettler PJ, Sarpatwari A. Lynch HF, et al. JAMA. 2018 Sep 4;320(9):869-870. doi: 10.1001/jama.2018.9880. JAMA. 2018. PMID: 30105394 No abstract available.
Using a drug-safety tool to prevent competition.
Sarpatwari A, Avorn J, Kesselheim AS. Sarpatwari A, et al. N Engl J Med. 2014 Apr 17;370(16):1476-8. doi: 10.1056/NEJMp1400488. N Engl J Med. 2014. PMID: 24738666 No abstract available.
Ensuring patient privacy in data sharing for postapproval research.
Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S. Sarpatwari A, et al. N Engl J Med. 2014 Oct 23;371(17):1644-9. doi: 10.1056/NEJMsb1405487. N Engl J Med. 2014. PMID: 25337755 No abstract available.
Progress and Hurdles for Follow-on Biologics.
Sarpatwari A, Avorn J, Kesselheim AS. Sarpatwari A, et al. N Engl J Med. 2015 Jun 18;372(25):2380-2. doi: 10.1056/NEJMp1504672. Epub 2015 May 6. N Engl J Med. 2015. PMID: 25946143 No abstract available.
The 21st century cures act: Opportunities and challenges.
Sarpatwari A, Kesselheim AS. Sarpatwari A, et al. Clin Pharmacol Ther. 2015 Dec;98(6):575-7. doi: 10.1002/cpt.208. Epub 2015 Oct 8. Clin Pharmacol Ther. 2015. PMID: 26264909
Such strong bipartisan support, rare in an age of congressional gridlock, might logically be interpreted as a sign of the Act's promise to foster innovative drug and device development. However, careful inspection reveals that while the Act contains some positive features, …
Such strong bipartisan support, rare in an age of congressional gridlock, might logically be interpreted as a sign of the Act's promi …
Experience With the Priority Review Voucher Program for Drug Development.
Kesselheim AS, Maggs LR, Sarpatwari A. Kesselheim AS, et al. JAMA. 2015 Oct 27;314(16):1687-8. doi: 10.1001/jama.2015.11845. JAMA. 2015. PMID: 26414802 No abstract available.
Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.
Yeh JS, Sarpatwari A, Kesselheim AS. Yeh JS, et al. Drug Saf. 2016 Aug;39(8):709-14. doi: 10.1007/s40264-016-0419-8. Drug Saf. 2016. PMID: 27000800
Boxed warnings-also known as "black box" warnings-can be a powerful tool in communicating drug risks to physicians and patients. ...For ethical and practical reasons, the FDA is justified in applying a higher standard for boxed warning removal than for imposition, a …
Boxed warnings-also known as "black box" warnings-can be a powerful tool in communicating drug risks to physicians and patients. ...F …
Efficacy of the Priority Review Voucher Program.
Sarpatwari A, Kesselheim AS. Sarpatwari A, et al. JAMA. 2016 Apr 19;315(15):1660-1. doi: 10.1001/jama.2016.0386. JAMA. 2016. PMID: 27092839 No abstract available.
State Initiatives to Control Medication Costs--Can Transparency Legislation Help?
Sarpatwari A, Avorn J, Kesselheim AS. Sarpatwari A, et al. N Engl J Med. 2016 Jun 16;374(24):2301-4. doi: 10.1056/NEJMp1605100. N Engl J Med. 2016. PMID: 27305189 No abstract available.
Navigating the Dermatological Drug Cost Curve.
Sarpatwari A, Kesselheim AS. Sarpatwari A, et al. JAMA. 2016 Jun 28;315(24):2724-5. doi: 10.1001/jama.2016.3851. JAMA. 2016. PMID: 27367767 No abstract available.
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