Results 241 to 250 of about 931,067 (298)
Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC): An infrastructure for accelerating regenerative therapies from discovery to clinical impact. [PDF]
J Clin Transl SciNguyen VX +14 more
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The Food and Drug Administration's role in supporting therapeutic development to address unmet needs: the National Academies report and beyond. [PDF]
Health Aff SchDhruva SS +3 more
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Thailand's Emerging Role in the Cell and Gene Therapy Revolution: A Review of Progress and Potential. [PDF]
Clin Transl SciViprakasit V +3 more
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Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization. [PDF]
Front Med (Lausanne)Niazi SK.
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Epilepsy Research, 2006
This report addresses: (1) a general update of FDA activity in areas relevant to AED development; (2) an update on issues relevant to the development of AEDs in the pediatric population; and (3) an update on the Agency's approach to the evaluation of AEDs as monotherapy.
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This report addresses: (1) a general update of FDA activity in areas relevant to AED development; (2) an update on issues relevant to the development of AEDs in the pediatric population; and (3) an update on the Agency's approach to the evaluation of AEDs as monotherapy.
openaire +2 more sources
New England Journal of Medicine, 2005
In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
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In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
openaire +2 more sources
Clinical Pharmacology & Therapeutics, 1967
This JOURNAL has avoided criticizing the FDA for its weaknesses and its failings because we have feIt that it is charged with a virtually impossible job. Certain recent actions of the FDA, however, violate basic principles of science and education, andhere the Editor feels that in the interest of the public and of medicine he must speak.
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This JOURNAL has avoided criticizing the FDA for its weaknesses and its failings because we have feIt that it is charged with a virtually impossible job. Certain recent actions of the FDA, however, violate basic principles of science and education, andhere the Editor feels that in the interest of the public and of medicine he must speak.
openaire +2 more sources