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  1. Histories of FDA Regulated Products

Summary of NDA Approvals & Receipts, 1938 to the present

A woman looking over several binders of information housed on a lab table.

Chemist Lee Geismer looking over an NDA in the 1960s

 

Introduction

The 1906 Food and Drugs Act prohibited the adulteration or misbranding of pharmaceuticals, but that law did not require premarket approval of drugs. As long as drugs were properly labeled and conformed to the applicable standard compendia—the U. S. Pharmacopoeia or the National Formulary, there was no federal statute to prevent their commercialization, safe or hazardous, effective or useless.

Congress considered some bills to correct this and other elements in the 1906 law, beginning in the early 1930s. Support for legislation was inadequate until 1937, when a manufacturer introduced an untested formulation of sulfanilamide with a solvent that was responsible for the deaths of over 100. In June of the following year President Roosevelt signed the Food, Drug, and Cosmetic Act, which completely revamped oversight of food and drugs and included for the first time consumer protection over medical devices and cosmetics.

The foundation of the drug provisions of the new law required manufacturers to submit to FDA evidence of a drug's safety before it could go on the market, and the agency had two months to approve, reject, or request additional data from the firm (failure to act on the application would theoretically lead to automatic de facto approval of the drug). This mandate for premarket evidence of a drug's safety represented the birth of the new drug application, or NDA.

A congressional investigation and subsequent hearings launched by Senator Estes Kefauver in the late 1950s raised many questions about drugs, including drug effectiveness. Consequently, the drug application itself changed substantially in 1962 when Congress amended the drug provisions of the law to require, among many other items, that manufacturers establish not only the safety but also the effectiveness of the drug through adequate and well-controlled clinical trials prior to marketing. These data were responsible for the expansion of the drug application into a massive document of perhaps hundreds of volumes.

There are several qualifications to the tabulation of new drug applications below that are cited in the footnotes. Unless stipulated otherwise, all data are derived from FDA publications over the years, such as its annual reports. Included are new molecular entities, which essentially are structurally unique active ingredients that have never before been marketed. Occasionally the footnotes explain abrupt shifts in the numbers of drugs approved or received. Otherwise, no assessment of changes in the data over time has been attempted.

 

Tabulation of New Drug Applications

 

Year NDAs Approved a New Molecular Entities NDAs Received a, b Commercial INDs Received Non-Commercial/Research INDs Received

Total INDs Received

1938            
1939            
1940 1782 (1938-40) 14 (1940 only) 2752 (1938-40)      
1941 807 17 1376      
1942   13 894      
1943 1028 (1942-43) 10 289      
1944 137 13 240      
1945 132 13 213      
1946 114 19 235      
1947 145 26 265      
1948 194 29 N/A      
1949 360 38 N/A      
1950 233 32 349      
1951 256 10 360      
1952 194 14 271      
1953 454 c 19 508 c      
1954 226 25 432      
1955 343 19 606      
1956 346 19 520      
1957 334 16 445      
1958 280 20 344      
1959 225 26 369      
1960 222 21 368      
1961 155 23 262      
1962 109 16 282      
1963 67 13 179     1066
1964 83 15 165     875
1965 53 18 203     761
1966 40 10 147     715
1967 189 16 271     671
1968 59 14 134     859
1969 38 5 71     956
1970 51 15 75     1120
1971 26 12 99     938
1972 57 10 448 d     976
1973 50 14 146     913
1974 85 21 106     842
1975 71 20 132 272 604 876
1976 72 22 142 258 627 885
1977 63 25 124 236 689 925
1978 86 17 121 233 692 925
1979 94 14 182 249 691 940
1980 114 12 162 269 818 1087
1981 96 27 129 247 937 1184
1982 116 28 202 297 1170 1467
1983 94 14 269 402 1396 1798
1984 142 22 217 391 1721 2112
1985 100 30 148 326 1578 1904
1986 98 20 120 332 1286 1618
1987 69 21 142 311 994 1305
1988 67 21 126 371 929 1300
1989 87 22 118 310 1004 1314
1990 64 23 98 382 1123 1505
1991 63 30 112 369 1661 2030
1992 91 26 100 370 2111 2481
1993 70 25 99 384 1848 2232
1994 62 22 114 341 1660 2001
1995 82 28 121 340 1394 1734
1996 131 53 120 389 1194 1583
1997 121 39 128 396 1186 1582
1998 90 30 121 441 1626 2067
1999 83 35 139 425 983 1408
2000 98 27 115 410 974 1384
2001 66 24 98 409 995 1404
2002 78 17 105 417 1338 1775
2003 72 21 109 391 972 1363
2004 119 e 36 e 115 621 e 1216 e 1837 e
2005 80 20 116 637 1297 1934
2006 101 22
124
713 1150 1863
2007
78
18
123
779 1810 2589
2008
89
24 140 886 1156 2039
2009
90
26
146
711 842 1553
2010
93
21
103
589 741 1330
2011
99
30
105
633 779 1412
2012 100 39 119 623 669 1292
2013 102 29 113 726 711 1437
2014 115 41 116 789 726 1515
2015 127 45 129 805 765 1570
2016 102 22 151 786 892 1678
2017 149 46 145 842 836 1678
2018 151 59 152 860 742 1602
2019 125 48 146 939 750 1689
2020 130 53 160 1266 930 2196
2021 125 50 138 1267 809 2076
2022 118 37 130 1129 741 1870

 

Notes

* Data through 1976 are reported for the fiscal year, 1 July through 30 June; data thereafter are reported for the calendar year. It is unknown if the de Haen data are based on calendar or fiscal years (see below).

a If both human and animal drugs are reported separately, only human drugs are listed.

b If data for original NDA submissions and NDA resubmissions are reported separately, only original NDA submissions are listed here.

c Reported as including both human and animal drugs; NDA approvals for this year are implied to include both as well.

d Includes 114 applications for radioactive drugs formerly regulated by the Atomic Energy Commission, and 94 applications for amphetamine drugs for obesity intended to demonstrate both safety and effectiveness.

e Approvals for 2004 and after include Biologic License Applications for therapeutic biologic products transferred from the Center for Biological Evaluation and Research to the Center for Drug Evaluation and Research.

 

Sources

NDAs received and approved 1938-1976: Federal Food, Drug and Cosmetic Law: Administrative Reports, 1907-1949 (Chicago: Commerce Clearing House, 1951); Food and Drug Administration, Annual Reports, 1950-1974 (Washington, D. C.: G. P. O., ca 1976); FDA,  Annual Report, 1975 ([Rockville, MD.: FDA], ca 1976); FDA,  Annual Report, 1976 ([Rockville, MD.: FDA], ca 1977).

NMEs approved 1940-1950: [Paul de Haen], "Compilation of New Drugs, 1940 thru 1975," Pharmacy Times 42, no. 3 (March 1976): 42.

NMEs approved 1951-1989: Document Management and Reporting Branch, Division of Management and Budget, Office of Management, Center for Drug Evaluation and Research, FDA, "Offices of Drug Evaluation: Statistical Report," typescript, 1989, pp. 152-199, FDA History Office Files, Rockville, Maryland. Note that the term "New Chemical Entity" was used instead of "New Molecular Entity" earlier in this period, but expressed the same concept.

NDAs received 1977-2006:  "Number of NDAs Received by Calendar Year," 16 January 2007, www.fda.gov/cder/rdmt/numofndareccy.htm.

NDAs received 2007-2022: FDA History Office Files, Silver Spring, MD. 

NDAs and NMEs approved 2007-2014: FDA History Office Files, Silver Spring, MD.

NDAs and NMEs approved 2015-2022https://www.fda.gov/drugs/nda-and-bla-approvals/nda-and-bla-calendar-year-approvals and https://www.fda.gov/drugs/nda-and-bla-approvals/new-molecular-entity-nme-drug-and-new-biologic-approvals

INDs received 1963-1969: William J. Gyarfas and Armond Welch, “The IND Procedure:  Assuring Safe and Effective Drugs,” in FDA Handbook of Total Drug Quality, FDA Publication No. 64 (Washington, D. C.:  G.P.O., 1970, pp. 31-34.

INDs received 1970-1974: FDA, Annual Reports, 1950-1974, and FDA, Annual Report, 1975.

INDs received 1975-1985: Office of Management, Center for Drugs and Biologics, FDA, “New Drug Evaluation Statistical Report (Briefing Book),” unpublished typescript, 1985, FDA History Office Files, Silver Spring, Maryland, and Office of Management, Center for Drug Evaluation and Research, FDA, “Office of Drug Evaluation Statistical Report,” unpublished typescript, 1990, FDA History Office Files, Silver Spring, Maryland.

INDs received 1986-2022https://www.fda.gov/drugs/ind-activity/ind-receipts, 26 October 2023, and FDA History Office Files, Silver Spring, Maryland (2009-2013)

NDAs approved 1977-2006, and NMEs approved 1990-2006: Office of Management, Center for Drugs and Biologics, FDA, "New Drug Evaluation Statistical Report (Briefing Book)," unpublished typescript, 1985, p. 58, FDA History Office Files, Rockville, Maryland; Document Management and Reporting Branch, Division of Management and Budget, Office of Management, Center for Drug Evaluation and Research, FDA, "Offices of Drug Evaluation: Statistical Report," typescript, 1993, p. 33, FDA History Office Files, Rockville, Maryland; and www.fda.gov/cder/rdmt/NDAapps93-06.htm, 29 January 2007.

NDAs and NMEs approved, and original NDA and BLA applications received 2007-2011: Center for Drug Evaluation and Research 2007 Update, “Improving Public Health Through Human Drugs,” http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/WhatWeDo/UCM121704.pdf; “Drug and Biologic Approval Reports: NDA and BLA Approvals,” and “Drug and Biologic Approval Reports: NME Drug and New Biologic Approvals,” http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/default.htm; and “FY 2011 Performance Report to the President and Congress for the Prescription Drug User Fee Act,” p. 6, http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/UCM294101.pdf (NDAs and BLAs received).”

 

Contact

Questions can be addressed to John P. Swann, Ph.D., FDA Historian, FDA History Office, White Oak Building 1, Room 1201, 10903 New Hampshire Avenue, Silver Spring, Maryland  20993, john.swann@fda.hhs.gov 

 

 

 
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