FDA Archives

Avoiding the Subject: On Pfizer Vaccine Quality Control, FDA Says Less than European Counterpart

Project on Government Oversight, March 19, 2021: The Project on Government Oversight’s new report about the Pfizer COVID Vaccine raises questions about why the FDA did not publicly disclose quality control concerns that were publicly raised in Europe. We ask: Is “adequate” quality control good enough?

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?

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.

Drug Industry Pushes FDA to Solve Growing Inspection Backlog

Politico, March 2, 2021: The FDA is under pressure from the pharmaceutical industry to address the growing backlog of drug inspections — nearly a year after Covid-19 prompted the agency to halt most plant visits. From March through September, FDA inspected just three plants outside the U.S. and 52 within the U.S., well below the 600 and 400, respectively in each of the prior two years. NCHR president reports device inspections have also dropped dramatically

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.