Por: The Hill Politics September 27, 2022
Lawmakers this week will advance a deal to fund drug and medical device evaluations at the Food and Drug Administration (FDA) for the next five years, but without any additional policy reforms. The agreement, which will be included as part of broader legislation to fund the government into December, represents a victory for Republican leaders who had insisted on a “clean” user fee bill before moving forward. On the House side, Energy and... + full article
ABC News USA Health September 30, 2022
WASHINGTON -- A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.Amylyx Pharmaceuticals said the Food and... + más
Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval | New York Post
ALS drug wins FDA approval despite questionable data | WPLG Local 10
WPLG Local 10 USA Politics September 30, 2022
WASHINGTON – A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.The Food and Drug Administration approved... + más
ALS drug wins FDA approval despite questionable data | ABC News
Associated Press USA Science September 30, 2022
WASHINGTON (AP) — A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.The Food and Drug Administration... + más
WPLG Local 10 USA Health September 24, 2022
WASHINGTON – The Food and Drug Administration acknowledged Tuesday that its response to the U.S. was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.A 10-page report from the agency offers its first formal... + más
FDA concedes delays in response to baby formula shortage | ABC News
‘If the FDA is expected to do more, it needs more’: FDA investigation into baby-formula crisis points to its own shortcomings. But shortages persist. | MarketWatch
The Hill USA Politics September 24, 2022
Sen. Richard Burr (R-N.C.) on Thursday said the five-year reauthorization of the Food and Drug Administration’s (FDA) user fee program will be included in the stopgap spending bill meant to prevent a government shutdown. Burr, who is the ranking member of the Senate Committee... + más
Health Care — White House: Graham abortion bill would be a ‘crisis’ | The Hill
ABC News USA Health September 21, 2022
WASHINGTON -- The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.A 10-page report from the agency... + más
FDA concedes delays in response to baby formula shortage | Associated Press
Internal FDA report on infant formula crisis details shortfalls in response | ABC News
Associated Press USA Politics September 21, 2022
WASHINGTON (AP) — The Food and Drug Administration acknowledged Tuesday that its response to the U.S. was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.A 10-page report from the agency offers its first... + más
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