Category Archives: FDA

The FDA pathway for biosimilar drug approvals

March 26, 2015- Interviewed by Steven E. Greer, MD

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The FDA’s new Breakthrough status for new drug applications

May 24, 2013- Interviewed by Steven E. Greer, MD Janet Woodcock, MD,

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Interview with The Commissioner of the FDA

February 16, 2011- by Steven Greer, MD In Part 1 of our interview with Margaret Hamburg, MD, The Commissioner of the FDA, she discusses

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CDER Director Janet Woodcock on new drug safety strategies

November 16, 2010- by Steven E. Greer, MD We interviewed Dr. Janet Woodcock, long-time Director of CDER, the FDA center responsible

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President-elect Trump adopts plan by The Healthcare Channel to bring back drug manufacturing jobs

Update January 11, 2017- By Steven E Greer, MD Last November, I sent my idea, below, directly to the Commissioner of the FDA, Robert Califf. I also sent it

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Interview with the CEO of Neovasc, Alexei Marko

Posted in - Medical Devices, Cardiology, FDA | Leave a comment

Interview with MannKind’s CEO, Al Mann, and CFO, Matt Pfeffer.

October 23, 2013- Interviewed by Steven E. Greer, MD The Healthcare Channel interviewed the CEO of MannKind, Al Mann, and the CFO, Matt Pfeffer.

Posted in - Medical Devices, Diabetes and endocrinology, FDA | Leave a comment

How the FDA regulates compounding pharmacies

April 5, 2015- Interviewed by Steven E. Greer, MD Few people knew what a compounding pharmacy was until a meningitis outbreak traced to the

Posted in - Policy, FDA | 1 Comment

Are the new PCSK9 cholesterol lowering drugs worth the high cost?

December 16, 2015- Interviewed by Steven E. Greer, MD

Posted in - Biotech, - NEJM, - Opinion, - Pharma, - Policy, Cardiology, CMS, FDA | Leave a comment

An emerging safety problem for TAVR patients

March 16, 2017- produced and interviewed by Steven E. Greer, MD We interviewed William O’Neill, MD, one of the first to implant a Transcatheter Aortic Valve Replacement (TAVR) valve. The products have been approved by the FDA for several years, … Continue reading

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The Lotus TAVR valve recall

March 16, 2017- produced and interviewed by Steven E. Greer, MD We interviewed William O’Neill, MD, one of the first to implant a Transcatheter Aortic Valve Replacement

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The Biggest Healthcare Stories of 2016

December 26, 2016- by Steven E. Greer, MD for The Healthcare Channel Policy changes dominated the 2016 year in healthcare news. There were few important new drug

Posted in - Biotech, - Generics, - Medical Devices, - Opinion, - Pharma, - Policy, - The Weekly Summary, CMS, FDA | Leave a comment

Is Vitamin-D deficiency overdiagnosed?

November 8, 2016- Interviewed by Steven E. Greer, MD We interviewed JoAnn E. Manson, MD, DrPH, Chief, Division of Preventive Medicine, Brigham

Posted in - NEJM, - Policy, CDC, Diabetes and endocrinology, FDA, Harvard, Primary care medicine | Leave a comment

The 23andMe home genetics test kit controversy

December 19, 2013- Interviewed by Steven E. Greer, MD In Part 1 of our interview with Robert Klitzman, MD, ethics professor at Columbia University, we

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Google wants your DNA now (Not just with 23andMe)

Opinion December 17, 2013- By Steven E. Greer, MD The Wall Street Journal published an article explaining how the pharmaceutical industry data mines

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The super shady methods of pricing generic drugs in America: case study- Sildenafil

May 15, 2016- by Steven E. Greer, MD The last I read, Teva and Mylan were not supposed to launch their approved generic of Viagra (sildenafil)

Posted in - Generics, - Opinion, - Pharma, CMS, Congress, FDA | Leave a comment

Early stoppage of clinical trials

April 16, 2009– Dr. Guyatt explained in a previous post why early stoppage of clinical trials results

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Robert De Niro gives credibility to vaccine truthers

Update March 27, 2016- Less than 24-hours after our story, this film has been pulled from the lineup. It was our story that got the heads of

Posted in - Pharma, - Reviews, books, devices, CDC, FDA, NIH, Pediatrics, Primary care medicine | Leave a comment

Man who oversaw one of the biggest academic research frauds in medical history is poised to become the next FDA Commissioner

Update February 7, 2016- Key senators, including Bernie Sanders, are now threatening to filibuster

Posted in - Opinion, - Policy, Cardiology, FDA, NIH | Leave a comment

Martin Shkreli, CEO of Turing Pharmaceuticals, could be the Bernie Madoff of the drug industry

September 22, 2015- by Steven E. Greer, MD Making national news today was Martin Shkreli, the baby-faced, greasy-haired, disheveled-looking

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