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Items: 1 to 20 of 1278

1.

Comparison of Observational Data and the ONTARGET Results for Telmisartan Treatment of Hypertension: Bull's-eye or Painting the Target Around the Arrow?

Califf RM.

JAMA Intern Med. 2017 Nov 20. doi: 10.1001/jamainternmed.2017.5091. [Epub ahead of print] No abstract available.

PMID:
29159401
2.

Remarks of the FDA Commissioner: The Food and Drug Law Institute's 59th Annual Conference.

Califf RM.

Food Drug Law J. 2016;71(2):201-10. No abstract available.

PMID:
29140062
3.

Finding ideal blood pressure targets in ischaemic stroke: prospective insight or retrospective guesswork?

Califf RM.

Eur Heart J. 2017 Oct 1;38(37):2836-2837. doi: 10.1093/eurheartj/ehx415. No abstract available.

PMID:
28982229
4.

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Öhman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF; EXSCEL Study Group.

N Engl J Med. 2017 Sep 28;377(13):1228-1239. doi: 10.1056/NEJMoa1612917. Epub 2017 Sep 14.

PMID:
28910237
5.

Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk.

Califf RM.

JAMA. 2017 Aug 15;318(7):614-616. doi: 10.1001/jama.2017.9412. No abstract available.

PMID:
28810004
6.

Cosmetics, Regulations, and the Public Health: Understanding the Safety of Medical and Other Products.

Califf RM, McCall J, Mark DB.

JAMA Intern Med. 2017 Aug 1;177(8):1080-1082. doi: 10.1001/jamainternmed.2017.2773. No abstract available.

PMID:
28655035
7.

Evaluating Evolving Technologies in a Time of Rapid Change: The Case of Transcatheter Aortic Valve Replacement.

Califf RM.

JAMA Cardiol. 2017 Aug 1;2(8):830-831. doi: 10.1001/jamacardio.2017.1733. No abstract available.

PMID:
28636721
8.

Warning About Shortcuts in Drug Development.

Califf RM.

J Am Heart Assoc. 2017 Mar 21;6(3). pii: e005737. doi: 10.1161/JAHA.117.005737. No abstract available.

9.

JACC: Heart Failure Series: FDA in the 21st Century: Focus on Nutrition and Heart Failure Prevention.

Fiuzat M, Mayne ST, Hillebrenner M, Stockbridge N, Zuckerman B, Califf RM.

JACC Heart Fail. 2017 Mar;5(3):229-231. doi: 10.1016/j.jchf.2016.12.012. Review. No abstract available.

PMID:
28254130
10.

Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM.

Nat Rev Drug Discov. 2017 May;16(5):297-298. doi: 10.1038/nrd.2017.25. Epub 2017 Feb 24.

PMID:
28232726
11.

FDA in the 21st Century: Focus on Tobacco Policies and Heart Failure Prevention.

Fiuzat M, Nordenberg TS, Zeller M, Hillebrenner MG, Stockbridge N, Zuckerman B, Califf RM.

JACC Heart Fail. 2017 Feb;5(2):152-153. doi: 10.1016/j.jchf.2016.11.010. No abstract available.

PMID:
28153199
12.

Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications.

Ferdinand KC, Senatore FF, Clayton-Jeter H, Cryer DR, Lewin JC, Nasser SA, Fiuzat M, Califf RM.

J Am Coll Cardiol. 2017 Jan 31;69(4):437-451. doi: 10.1016/j.jacc.2016.11.034. Review.

13.

Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance.

Califf RM.

JAMA. 2017 Feb 21;317(7):693-694. doi: 10.1001/jama.2017.0410. No abstract available.

PMID:
28114599
14.

Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration.

Rappel MJ, Hunter NL, Alexandrow AI, Hair KO, Sherman RE, Califf RM.

Clin Transl Sci. 2017 May;10(3):124-127. doi: 10.1111/cts.12441. Epub 2017 Feb 14. No abstract available.

15.

The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Cardiovascular Drug Development.

Stockbridge N, Miller K, Amur S, Hillebrenner M, Zuckerman B, Fiuzat M, Califf RM.

JACC Heart Fail. 2017 Jan;5(1):67-70. doi: 10.1016/j.jchf.2016.10.009. Review. No abstract available.

PMID:
28034379
16.

Regarding "Eteplirsen for the treatment of Duchenne muscular dystrophy".

Unger EF, Califf RM.

Ann Neurol. 2017 Jan;81(1):162-164. doi: 10.1002/ana.24842. No abstract available.

PMID:
27997035
17.

Transforming Evidence Generation to Support Health and Health Care Decisions.

Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, Coster TS, Cunningham FE, De Lew N, DeSalvo KB, Dymek C, Dzau VJ, Fleurence RL, Frank RG, Gaziano JM, Kaufmann P, Lauer M, Marks PW, McGinnis JM, Richards C, Selby JV, Shulkin DJ, Shuren J, Slavitt AM, Smith SR, Washington BV, White PJ, Woodcock J, Woodson J, Sherman RE.

N Engl J Med. 2016 Dec 15;375(24):2395-2400. No abstract available.

18.

Clarifying Stem-Cell Therapy's Benefits and Risks.

Marks PW, Witten CM, Califf RM.

N Engl J Med. 2017 Mar 16;376(11):1007-1009. doi: 10.1056/NEJMp1613723. Epub 2016 Nov 30. No abstract available.

PMID:
27959704
19.

Real-World Evidence - What Is It and What Can It Tell Us?

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM.

N Engl J Med. 2016 Dec 8;375(23):2293-2297. No abstract available.

PMID:
27959688
20.

The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Heart Failure Devices.

Hillebrenner M, Zuckerman B, Fiuzat M, Stockbridge N, Califf R.

JACC Heart Fail. 2016 Dec;4(12):974-977. doi: 10.1016/j.jchf.2016.09.007. No abstract available.

PMID:
27908396

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