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Highlighting Major Issues Critical to FDA

Highlighting Major Issues Critical to FDA

Mar 16, 2023

By Robert M. Califf MD – Recently I marked my one-year anniversary as the 25th Commissioner for Food and Drugs. I have been proud to represent the U.S. Food and Drug Administration and its talented and hard-working staff in these extraordinary times.

CMS Statement on FDA Accelerated Approval of Lecanemab

CMS Statement on FDA Accelerated Approval of Lecanemab

Jan 10, 2023

CMS is releasing the following statement from Administrator Chiquita Brooks-LaSure, with accompanying background information, in response to the action by the FDA to grant accelerated approval to a new product designed to treat Alzheimer’s disease.

FDA Recognizes National Immunization Awareness Month

FDA Recognizes National Immunization Awareness Month

Aug 16, 2022

By Robert M. Califf MD – National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health.

KHN’s ‘What the Health?’: It’s Health Costs, Stupid (2022 Edition)

KHN’s ‘What the Health?’: It’s Health Costs, Stupid (2022 Edition)

Feb 28, 2022

From Kaiser Health News Network – Their latest podcast, What the Health, The pandemic may be showing signs of winding down, but health care costs are not. In Massachusetts, a fight is shaping up over whether one of the most prestigious hospital systems needs to save money, while antitrust cases…

‘An Arm and a Leg’: The Rapid-Test Edition: Who’s Making a Buck?

‘An Arm and a Leg’: The Rapid-Test Edition: Who’s Making a Buck?

Jan 4, 2022

From Kaiser Health News Network – Their latest podcast, ‘An Arm And A Leg’, This week, Rapid, at-home covid-19 tests are close to essential if you want to see friends and family this holiday season, and do your best to stay safe. But they’re freaking expensive and can be hard to find. What the heck happened?

Pharma Update 12-20-21

Pharma Update 12-20-21

Dec 20, 2021

The pharmaceutical market plays a key role in how people get medications and what people pay for medication. At the intersection of healthcare, pharma, and technology, here are current news and announcements.

HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests

HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests

Dec 2, 2021

The HHS and the FDA are committed to helping ensure that COVID-19 tests are accurate, reliable, and available. As part of that commitment, HHS is withdrawing a policy established during the previous administration that limited FDA’s ability to address certain problematic COVID-19 tests.

Health IT Product News Report

Health IT Product News Report

Oct 18, 2021

Health IT product news from Remove term: Aidoc, Arterys, Bamboo Health, Cynerio, ePlus, FDA, Firefly Health, Lightbeam Health Solutions, OneMedNet Corporation, Updox and more.

Public Health Experts ‘Flabbergasted’ That Biden Still Hasn’t Picked an FDA Chief

Public Health Experts ‘Flabbergasted’ That Biden Still Hasn’t Picked an FDA Chief

Sep 27, 2021

By Rachana Pradhan – President Joe Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it’s baffling for the agency to be without a permanent leader during a national health crisis.

Pharma Update 9-20-21

Pharma Update 9-20-21

Sep 20, 2021

The pharmaceutical market plays a key role in how people get medications and what people pay for medication. At the intersection of healthcare, pharma, and technology, here are current news and announcements.

KHN’s ‘What the Health?’: Vaccine Approval Moves the Needle on Covid

KHN’s ‘What the Health?’: Vaccine Approval Moves the Needle on Covid

Sep 8, 2021

From Kaiser Health News Network – Their latest podcast, What the Health, The FDA gave full approval to the covid-19 vaccine from Pfizer and BioNTech, which will henceforth be known as “Comirnaty.” It is not clear how many vaccine-hesitant Americans will now be willing to get a jab, but the approval has prompted many public and private employers to implement mandates for their workers.

Pharma Update 6-28-21

Pharma Update 6-28-21

Jun 28, 2021

The pharmaceutical market plays a key role in how people get medications and what people pay for medication. At the intersection of healthcare, pharma, and technology, here are current news and announcements.

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