Washington Monthly, March 26, 2021: Not since the polio vaccine became available in April 1955 have Americans been so excited about getting a shot. But behind the scenes, there’s a lot we don’t know because of a decision made back in December by the FDA. The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines, making it impossible to learn how long the vaccines work and for whom.
Read More »Tag: FDA regulation
Birth Control Apps Show the Contradictions in FDA Device Oversight
The Verge, March 17, 2021: The FDA has allowed a second digital birth control app to be sold in the U.S. Neither Natural Cycles nor Clue were tested in clinical trials. NCHR asks how safe and effective are they, and are women being misled?
Read More »Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors
STAT News, March 1, 2021: The FDA is approving more new cancer drugs than ever before, after FDA’s drug chief Janet Woodcock loosened FDA standards. Now cancer doctors are Woodcock’s most vocal backers in her campaign to be FDA Commissioner. But critics say too many approved cancer drugs aren’t proven to help patients live longer.
Read More »What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine
ScienceNews: February 27, 2021. On February 27, the FDA authorized Johnson & Johnson’s COVID-19 vaccine for use in the U.S. The other two authorized vaccines are made by Pfizer and Moderna. None are FDA approved. All show effectiveness, but there are too few serious COVID-19 cases in any of the studies to conclude how well it prevents hospitalizations or deaths.
Read More »Who Will Be the Next F.D.A. Chief?
The New York Times: February 20, 2021. One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review. This has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.
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