The COVID-19 pandemic has reminded all that track health, research and the impact of disease on minority and underserved or at risk populations. Racial and ethnic minorities such as African Americans and Hispanics, for example are disproportionately impacted by the...
Food and Drug Administration
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FDA Issues Guidance for IRBs to Help them Review Individual Expanded Access Submissions for COVID-19 Therapies
COVID-19 ushered in an unprecedented public health crisis. America’s drug and device regulatory, the U.S. Food and Drug Administration (FDA), recently released new guidance for Institutional Review Board (IRB) and clinical investigators to confront individual patient...
FDA Champions Recovered COVID-19 Patients to Consider Donating Plasma for Development of Blood-based Therapies
The U.S. Food and Drug Administration (FDA), embracing the All-of-America approach to fighting the COVID-19 pandemic, updates the country on a treatment called convalescent plasma, encouraging those who have recovered from COVID-19 to donate plasma to help others...
FDA Cautions People Not to Take Ivermectin for COVID-19
Recently, TrialSite News reported on an Australian research team (Monash University & Peter Doherty Institute) uncovering the potential that ivermectin could potentially be used as a treatment against COVID-19. Recently, the U.S. Food and Drug Administration (FDA)...
Could Adverse Drug Reactions (ADRs) be the Fourth Biggest Killer in America?
Physicians should learn more about Adverse Drug Reactions or ARDs because they are one of the leading causes of morbidity and mortality in the United States. Recently, the U.S. Food and Drug Administration (FDA) published a “learning module” developed based on a needs...
FDA Already Issues 7 Warning Letters to Hucksters Selling COVID-19 ‘Cures’
The Food and Drug Administration’s (FDA) Dr. Stephen Hahn unfortunately had to issue a statement today notifying the population to be on the look out for quacks, hucksters, and frauds. Clearly concerned about real world events unfolding, Dr. Hahn declared that...
FDA Introduces Guidance on Conduct of Clinical Trials During the COVID-19 Pandemic
The U.S. Food and Drug Administration (FDA) issued guidance for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic, the agency recently announced. The agency is exhibiting a pragmatic sense of...
With Big Wave of Gene Therapy Products Moving to Clinical Trials FDA Prepares with More Guidance
To date, the U.S. Food and Drug Administration (FDA) has approved four gene therapy products, which insert new genetic material into a patient’s cells. The agency expects a boom in gene therapy product approvals in the coming decade as evidenced by the more than 900...
Pharma Warning Letters Spike in U.S. with Big Drop in China; India Up 13%
The Indian press publicized Indian pharma companies overall improving track record by pointing to U.S. FDA inspection-driven warning letters targeting American-based companies—these pharma domestic company write-ups spiked 184% in 2019. While there is a “perception”...
FDA Approves More Drugs & Faster but Are Drugs Better and Patients Safer? A Harvard Study Questions
The Food and Drug Administration’s (FDA) attempts at expediting and streamlining the approval of advanced new medicines is surely appreciated by those in the public that understand the importance of access to such therapies to address serious disease. And in fact,...
MD Anderson Cancer Center Top Medical Executive Confirmed to Run the FDA
MD Anderson Cancer Center chief medical executive Stephen Hahn has been confirmed by the U.S. Senate as FDA commissioner. On December 12, the Senate voted 72-18 to confirm Dr. Hahn. He will become the 24th FDA commissioner, succeeding Scott Gottlieb. He has served MD...