Category Archives: FDA

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

The FDA pathway for biosimilar drug approvals

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

Posted in - Biotech, - Generics, 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

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

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

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

Hormone replacement therapy is safe and effective after all

November 14, 2017- Interviewed by Steven E. Greer, MD We interviewed JoAnn Manson, MD, DrPH about her JAMA paper that followed the cohorts in

Posted in - JAMA, Cardiology, Diabetes and endocrinology, FDA, Geriatrics, Harvard, Obstetrics and Gynecology, Oncology, Orthopedic surgery, Primary care medicine | Leave a comment

FDA CDER Director on Benlysta for lupus and adaptive clinical trials.

July 27, 2011- Janet Woodcock, MD, Director of the FDAs new drug division, CDER, discusses with Steven Greer,

Posted in - Biotech, - Pharma, FDA, Rheumatology | 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

Is President Trump on amphetamines? (Yes, he is)

Update January 16, 2018- by Steven E. Greer, MD President Trump’s doctor confirms my diagnosis made in the story below, which was that the slurred

Posted in - Opinion, - Pharma, - Policy, FDA, Internal Medicine, Neurology, Primary care medicine, Rehab | Leave a comment

NBC begins alarming new series to promote the diagnosis of “mental illness” in children

December 11, 2017

Posted in - Opinion, - Pharma, - Policy, CDC, Congress, FDA, Neurology, Neurosurgery, NIH, Pediatrics, Primary care medicine, Psychology Psychiatry, Rehab | Leave a comment

Oh my god, I have a disease!

March 21, 2014- This DTC TV drug ad medicalizing a non-disease really struck us as egregious

Posted in - Pharma, Congress, FDA | Leave a comment

The serious adverse events caused by antipsychotics

February 1, 2014

Posted in - Pharma, FDA | Leave a comment

How pain pills almost killed my mother after elective knee surgery

May 21, 2014- By Steven E. Greer, MD My mother is in her 70’s and in good health except for debilitating knee arthritis. After considerable

Posted in - Opinion, - Policy, CDC, Congress, FDA, Orthopedic surgery, Plastic surgery | Leave a comment

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

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

Posted in - Pharma, FDA | Leave a comment

The 23andMe home genetics test kit controversy

December 19, 2013- Interviewed by Steven E. Greer,  MD

Posted in Columbia, FDA, Genetics, NIH, Oncology, Psychology Psychiatry | Leave a comment

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

Posted in - Opinion, - Policy, FDA, Genetics | Leave a comment

Interview with the CEO of Neovasc, Alexei Marko

Posted in - Medical Devices, Cardiology, 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

Posted in Cardiac surgery, FDA, McMaster University | Leave a comment

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

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

CBS News Promotes More Pro-Coffee Junk Science

July 11, 2017- by Steven E. Greer, MD How does one become a successful TV medical doctor pundit? First, you have to leave your medical ethics

Posted in - Opinion, Cardiology, CDC, Congress, Cornell, FDA, Primary care medicine, Psychology Psychiatry | Leave a comment