By Robert M Califf MD & Kaveeta P. Vasisht MD PharmD – Thirty years ago, the U.S. Food and Drug Administration’s Office of Women’s Health was established to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women.
By David Hilzenrath & Holly K. Hacker – When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.
By Robert Califf – At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential. Some in the nonscientific community may be surprised by the seemingly sudden amount of attention on AI.
By Robert Califf – Recently I wrote about my recent trip to India, a trip largely motivated by the enormous need for coordinated effort on the common imperative in the U.S. and the rest of the world for readily available, high-quality generic drugs. I also relished the chance to visit a fascinating country and renew many friendships.
By Robert M. Califf MD – Biomedical and healthcare progress is dependent upon research that informs our decisions. The clinical trial is the most reliable method to determine the benefits and risks of interventions. The formation of ClinicalTrials.gov in February 2000 was a major step forward by providing a public record of trials.
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 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.
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.
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…
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?
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.
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.
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