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The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...
Capricor Therapeutics (CAPR) shares fell Friday after the company announced it received a complete response letter from the FDA for its Biologics License Application for Deramiocel.
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
The FDA on Thursday said it published more than 200 decision letters, known as complete response letters, that it issued in response to applications for approval of drugs or biological products ...
Guam faces a historic opportunity through Bill 102-38, the Guam Tariff Advantage Development Act.
Patricia L. Diego, a Masters of Public Administration candidate at the University of Guam in early May wrote a letter to President Donald Trump, requesting him to appoint his personal ...
Obesity is associated with financial hardship and food insecurity, according to a research letter published online June 24 in ...
Letters: Universities have many revenue streams and it is time they also lose their nonprofit status, or at the very least, be required to reinvest 10% of their endowment annually in funding and su… ...