The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...
Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.
CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...
Discover how drugs prevent, cure, and alleviate ailments. Learn about over-the-counter vs. prescription drugs and the pharmaceutical industry's impact on healthcare.
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