The issues addressed in these letters are usually related to "safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues." HealthDay News — The US Food and Drug Administration ...
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. The attempt may have created more questions, however, with only certain ...
The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response ...
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency ...
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
The goal is to improve public understanding of the FDA decision-making process. (HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or ...
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