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Table representation of search results timeline featuring number of search results per year.

Year Number of Results
1944 1
1945 2
1946 1
1947 3
1948 2
1949 2
1952 1
1953 2
1954 2
1955 3
1956 18
1957 8
1958 2
1959 3
1960 5
1961 6
1962 2
1963 17
1964 41
1965 46
1966 67
1967 66
1968 90
1969 87
1970 124
1971 112
1972 160
1973 186
1974 230
1975 207
1976 209
1977 219
1978 352
1979 372
1980 344
1981 329
1982 340
1983 387
1984 364
1985 432
1986 385
1987 425
1988 531
1989 612
1990 676
1991 804
1992 927
1993 983
1994 928
1995 1139
1996 1257
1997 1299
1998 1662
1999 1632
2000 1557
2001 1732
2002 1994
2003 2161
2004 2484
2005 2417
2006 2712
2007 2945
2008 3057
2009 3153
2010 3600
2011 4020
2012 4363
2013 4502
2014 5105
2015 5592
2016 5905
2017 6288
2018 6746
2019 7160
2020 8837
2021 9669
2022 9132
2023 9132
2024 9769
2025 977

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130,156 results

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Page 1
Califf for the FDA.
Drazen JM. Drazen JM. N Engl J Med. 2016 Jan 14;374(2):176-7. doi: 10.1056/NEJMe1513828. Epub 2015 Oct 28. N Engl J Med. 2016. PMID: 26509719 No abstract available.
Food and Drug Administration.
Horton LR. Horton LR. BMJ. 2007 Jan 13;334(7584):55-6. doi: 10.1136/bmj.39049.545880.BE. BMJ. 2007. PMID: 17218671 Free PMC article.
Checks and Balances on FDA's Authority.
Lynch HF, Lurie P, Cohen IG. Lynch HF, et al. JAMA. 2024 Sep 3;332(9):705-706. doi: 10.1001/jama.2024.11987. JAMA. 2024. PMID: 38889181
In this Viewpoint, the authors refute recent suggestions that the US Food and Drug Administration (FDA) is not accountable for its decisions, pointing out the legal, legislative, and executive checks and balances on the agency....
In this Viewpoint, the authors refute recent suggestions that the US Food and Drug Administration (FDA) is not a …
MRI-related FDA adverse event reports: A 10-yr review.
Delfino JG, Krainak DM, Flesher SA, Miller DL. Delfino JG, et al. Med Phys. 2019 Dec;46(12):5562-5571. doi: 10.1002/mp.13768. Epub 2019 Oct 8. Med Phys. 2019. PMID: 31419320 Review.
PURPOSE: To provide an overview of the types of adverse events reported to the US Food and Drug Administration (US FDA) for magnetic resonance (MR) systems over a 10-yr period. ...Objects that became projectiles were also categorized. RESULTS: FDA …
PURPOSE: To provide an overview of the types of adverse events reported to the US Food and Drug Administration (US F …
The FDA process for the evaluation and approval of orthopaedic devices.
Kirkpatrick JS, Stevens T. Kirkpatrick JS, et al. J Am Acad Orthop Surg. 2008 May;16(5):260-7. doi: 10.5435/00124635-200805000-00004. J Am Acad Orthop Surg. 2008. PMID: 18460686 Review.
The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed t …
The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority …
Bioequivalence for highly variable drugs: regulatory agreements, disagreements, and harmonization.
Endrenyi L, Tothfalusi L. Endrenyi L, et al. J Pharmacokinet Pharmacodyn. 2019 Apr;46(2):117-126. doi: 10.1007/s10928-019-09623-w. Epub 2019 Feb 23. J Pharmacokinet Pharmacodyn. 2019. PMID: 30798390 Review.
These approaches are similar in principle but differ in details. For example, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommend differing regulatory constants. ...The procedure for the FDA approach is based …
These approaches are similar in principle but differ in details. For example, the Food and Drug Administration (FDA …
Antimicrobial Dose Selection under the Animal Rule.
Wu K, Choi SY, Bergman K, Seo S. Wu K, et al. Clin Pharmacol Ther. 2021 Apr;109(4):971-976. doi: 10.1002/cpt.2201. Epub 2021 Mar 6. Clin Pharmacol Ther. 2021. PMID: 33565088 Review.
The Food and Drug Administration's (FDA's) "Animal Rule" provides a unique regulatory pathway for drugs and biologics intended to treat serious or life-threatening conditions caused by exposure to lethal or permanently disabling chemical, biological, r …
The Food and Drug Administration's (FDA's) "Animal Rule" provides a unique regulatory pathway for drugs and biol …
How drugs are developed and approved by the FDA: current process and future directions.
Ciociola AA, Cohen LB, Kulkarni P; FDA-Related Matters Committee of the American College of Gastroenterology. Ciociola AA, et al. Am J Gastroenterol. 2014 May;109(5):620-3. doi: 10.1038/ajg.2013.407. Am J Gastroenterol. 2014. PMID: 24796999 Review.
OBJECTIVES: This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near fut …
OBJECTIVES: This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimat …
The Mifepristone Case and the Legitimacy of the FDA.
Gluck AR. Gluck AR. JAMA. 2023 Jun 27;329(24):2121-2122. doi: 10.1001/jama.2023.8712. JAMA. 2023. PMID: 37266955
This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Administration's (FDA) approval of mifepristone, a drug used to end pregnancies and manage miscarriage when used with misoprostol, and how that decision c …
This Viewpoint discusses a recent federal court decision that invaliated the Food and Drug Administration's (FDA …
Data Integrity: History, Issues, and Remediation of Issues.
Rattan AK. Rattan AK. PDA J Pharm Sci Technol. 2018 Mar-Apr;72(2):105-116. doi: 10.5731/pdajpst.2017.007765. Epub 2017 Nov 20. PDA J Pharm Sci Technol. 2018. PMID: 29158286 Review.
Data integrity is critical to regulatory compliance, and the fundamental reason for 21 CFR Part 11 published by the U.S. Food and Drug Administration (FDA). FDA published the first guideline in 1963, and since then FDA and European Union …
Data integrity is critical to regulatory compliance, and the fundamental reason for 21 CFR Part 11 published by the U.S. Food and …
130,156 results
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