Bloomberg Law, December 22, 2021: The FDA authorized Pfizer Inc.’s pill to treat Covid-19 without first getting input from an expert advisory panel. We explain why that could further undermine trust in an agency already facing scrutiny over its rapid decision-making during the pandemic.
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Califf heads to Capitol Hill for FDA confirmation hearing
Politico, December 14, 2021: FDA Commissioner nominee Dr. Robert Califf makes his case for the job before the Senate health panel. We ask: What will he do about accelerated approval of ineffective medical treatments?
Read More »NCHR’s Testimony to FDA on the BrainsGate Ischemic Stroke System
December 10, 2021. We agree with the FDA reviewers that the data presented today do not support the claim that the specific device that the company plans to market is either reasonably safe or reasonably effective.
Read More »Biden’s Drug Agency Nominee Returns With Deeper Industry Ties
Bloomberg Business, November 23, 2021: President Biden’s choice to lead the FDA made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.
Read More »The road ahead for Califf’s confirmation
Axios and Yahoo News, November 15, 2021: Former FDA chief Robert Califf has been nominated to head the agency again. We tell Axios that “The public has been asking if they can trust the FDA to ensure that the benefits outweigh the risks for Alzheimer’s drugs, cancer treatments, and implanted devices”
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