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FDA still lacks standing committee

The Biden administration has scrutinized candidates other than Dr. Woodcock, but no one has been publicly announced as a candidate in the sixth month of his presidency. A White House spokesman did not comment on late or controversial candidates. However, among those who are said to be still in action are Dr. Joshua Sharfstein, a former FDA official and vice president of public health at Johns Hopkins University, and Florence, a former FDA official and former vice president. Includes Dr. Haun. The president of Celgene, who is currently working as a consultant.

A recent addition to the roster is Dr. Michelle McMurry-Heath, a physician and molecular immunologist who was the FDA’s Associate Science Director during the Obama administration. However, Dr. McMurray Heath’s candidacy will be complicated by her current job as chairman of the Biotechnology Industry Association, which lobby on behalf of biotechnology companies.

In an interview, current and former FDA employees and industry executives cited some imminent priorities as the country emerged from the coronavirus pandemic that struck the country.

Authorities will soon decide whether to give permanent approval to the three Covid vaccines already widely distributed under an emergency use authorization, Pfizer-BioNTech, Moderna, Johnson & Johnson. AstraZeneca and Novabax will soon submit an application for an emergency use authorization for the vaccine. They have completed data collection from a US Phase 3 trial. AstraZeneca is already licensed in other countries, but its use is restricted in some countries due to side effects. Novavax has not yet been approved elsewhere. Sanofi is also in Phase 3 of clinical trials and will be applied in the fall.

The federal government has poured more than $ 19 billion into vaccines, less than half of which was used for treatment. The Biden administration is calling for a new focus on the development of treatments for Covid and its complications. Some treatments, such as remdesivir, monoclonal antibodies, and steroid dexamethasone, have improved outcomes in some Covid patients, but not in all.

The FDA has promised a new system known as BEST for tracking side effects on the Covid vaccine. But it’s still not working as promised. Meanwhile, the FDA and the US Centers for Disease Control and Prevention are seriously deficient, primarily because they rely on patients and healthcare providers to report what they believe to be a bad response to the vaccine without providing evidence. It relies heavily on older tracking systems that admit that there is. .. Government agencies are increasing pressure to modify the system.

For years, clinics, academic institutions, and commercial laboratories have pressured the FDA to develop its own in-house tests for a variety of illnesses without government oversight. The FDA has resisted for as long. However, in August, the Trump administration used tests developed in these labs to enable the detection of numerous diseases, including Covid-19, without first confirming that they function. I ordered

FDA still lacks standing committee

Source link FDA still lacks standing committee

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