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LEGEND:
Note: The numbers next to each entry indicate the
pages in the text where that term appears.
TL = Time Line (with date)
CDER = CDER Administrators page
intro = patent medicine introduction
FDA = FDA Administrators page
gallery = patent medicine pages
bio = biography section
A
abbreviated new drug applications (ANDAs)
creation of 37
for generic drugs 53, 59
Ad Hoc Science Advisory Committee (Ritts Committee) 42
adverse drug reaction reporting
FDA offices responsible for 34, 40
National Drug Experience Reporting System 43
strengthening of reporting requirements 56
study of 25
advisory committees/boards
Ad Hoc Science Advisory Committee (Ritts Committee) 42
Advisory Committee on the FDA, final report 60 [photo]
Citizens Advisory Committee 26 [photo], 27
FDA Advisory Committee on Investigational New Drugs TL
(1963), 33
Generic Drugs Advisory Committee 59
Medical Advisory Board 39
Oncologic Drugs Advisory Committee meeting 62 [photo]
AIDS 57, 58
AIDS Coalition to Unleash Power, protest 56
[photo]
testing kit 55 [photo]
Understanding AIDS pamphlet 58 [photo]
Animal Drug Amendments [1968] TL
awards/prizes
Distinguished Federal Civilian Service Award [1962] 31 [photo]
Ebert Prize [1929] 15
B
Boots Pharmaceuticals 52
Bureau By-Lines 29
Bureau of Biologics 47
Bureau of Chemistry 2, 3, 10, 29 [photo]
C
Center for Biologics Evaluation and Research (CBER) 59
Center for Drug Evaluation and Research (CDER) 1, 63
administrators CDER [photo]
agencies that preceded CDER
Bureau of Drugs [1969] (replaces Bureau of Medicine) 41
reorganized 1974 43
reorganized 1980s 47, 48
Bureau of Medicine [1957] (replaces Div. of Medicine) 27, 29, 35, 39
reorganized 1965 39
reorganized 1966 41
Division of Medicine [1945] (replaces Drug Division) 23
Drug Division (or Division of Drugs) [1908] 4,
5, 6, 8, 9,10,11
Drug Division (of FDA) [1935] 17, 20, 22, 23
Drug Laboratory [1902] 2, 3, 4
National Center for Drugs & Biologics [early 1980’s] 47
Organizational Overview & Structure Report 47 [photo]
reorganized 1984-1986 49, 50, 54, 55
Office of Drug Administration [early 1920s] 10,
11
Office of Drug Control [1923] 11, 12, 13, 14, 15, 16
Office of Special Collaborative Investigations 10, 14
creation of [1987] 57, 58
organizational changes 58, 59, 60
reorganized [1995] 62
chemist at work 39 [photo]
Citizens Advisory Committee 26 [photo], 27
clinical trials
Division of Clinical Pharmacology, role of 60
Investigational Drug Branch, role of 34
Kefauver-Harris Amendments (Drug Amendments of 1962) 33
Collier’s Weekly
Death’s Laboratory, cover [1906] 3
[photo]
The Great American Fraud intro,
TL (1905)
companies
Boots Pharmaceuticals 52
Massengill 18
William Merrell Company 31
Comprehensive Drug Abuse Prevention & Control Act [1970] TL
Congressional hearings
Fountain hearings 36
Kefauver hearings 30
Court cases
Upjohn v. Finch TL (1968)
U.S. v. Cardiff TL (1952)
U.S. v. Johnson TL (1911), 7
U.S. v. Sullivan TL (1948)
D
DESI (Drug Efficacy Study Implementation) TL (1968), 37
Drug Abuse Control Amendments [1965] TL
drug advertising and marketing 40
direct to consumer television advertising 52
Nashville Banner article, 1983 52
[photo]
Federal Food, Drug and Cosmetic Act 19
Federal Trade Commission TL (1938), 19
Kefauver-Harris Amendments (Drug Amendments of 1962) 32
of generic drugs 53 [photo]
of patent medicines intro
Prescription Drug Marketing Act 56
Drug Amendments of 1962 (Kefauver-Harris Amendments) TL, 32,
33, 34,37
drug analysis 13, 22
by Drug Laboratory 2, 3
of ergot 15
drug devices
FDA offices responsible for 29, 41
drug effectiveness
Drug Efficacy Study Implementation (DESI) 37
Kefauver-Harris Amendments (Drug Amendments of 1962) 32
National Center for Drugs and Biologics 47,
48
new drug applications (NDAs) 34
of generic drugs 59
of over-the-counter drugs 38
U.S. v. Johnson case 7
Drug Enforcement Administration TL (1968)
Drug Importation Act [1848] TL
drug labeling
abbreviated new drug applications (ANDAs) 37
FDA offices responsible for 22, 46
fraudulent 9
Office of Drug Administration 10
of over-the-counter drugs 38
Pure Food and Drugs Act 4
required for all new drugs 21
Sherley Amendment 7, 9
U.S. v. Johnson case 7
Drug Price Competition and Patent Term Restoration Act of 1984 TL, 53
Drug Regulation Reform bill [1978] 44, 45
drug safety
anesthetics investigation 13
antibiotics 32
Congressional hearings 36
diethylene glycol 18
dinitrophenol investigation 16
Durham-Humphrey Amendment of 1951 24
Elixir Sulfanilamide disaster TL (1937), 18
Federal Anti-Tampering Act 51
Federal Food, Drug and Cosmetic Act 19
Insulin Amendment 21
Kefauver-Harris Amendments (Drug Amendments of 1962) 32, 33, 36, 37
National Center for Drugs and Biologics 47
over-the-counter (OTC) drug reviews 38
package inserts TL (1970), 45
Penicillin Amendment 21
thalidomide (Kevadon) TL (1962), 31, 32
drug testing
effects of drugs on animals 6
list of studies of drug samples 42
[photo]
National Center for Drug Analysis (NCDA) 42
of all new drugs 19
of insulin and penicillin 21
drugs/drug substances
caffeine 6
chloramphenicol (chloromycetin) TL (1952), 25 [photo]
chloroform 8
diethylene glycol 18
digitalis 12
dinitrophenol 16 [photo]
disopyramide (Norpace) 54
Elixir Sulfanilamide TL (1937), 18 [photo]
ether 13
ethylene 13
ibuprofen (Rufen brand) 52
insulin TL (1941), 21, 28, 35
Johnson’s Mild Combination Treatment for Cancer 7
morphine intro, 8
nicotine TL (1994)
nitroglycerin 8
oil of wintergreen 5
panhematin 51 [photo]
penicillin TL (1945), 21, 22 [photo]
potassium iodide 46 [photo]
radol 6 [photo]
root-beer extract 5
sulfa-sugracillin 37 [photo]
sulfathiozole TL (1941)
thalidomide (Kevadon) TL (1962), 31, 32
Tylenol TL (1982), 51
drugs, categories of
amphetamines 27 [photo]
anesthetics 13
antibiotics 21, 28,
29, 30, 32, 35, 39, 48
barbituates 27 [photo]
crude drug products 9, 11
experimental drugs TL (1987), 56
generic drugs TL (1984), 53 [photo], 59
headache remedies 5
narcotics [1914] TL (1914), 38 [photo]
oral contraceptives TL (1970), 45
orphan drugs TL (1983), 51
over-the-counter drugs TL (1972), 24, 38 [photo], 62
reagents 2
weight reduction 16
Durham-Humphrey Amendment of 1951 TL, 24
E
enforcement 6, 27
[photo]
ergot pharmacology, study of 15
Essential Oils Laboratory, Division of Drugs 5
[photo]
F
Factory Inspection Amendment [1953] TL
FDA Advisory Committee on Investigational New Drugs TL (1963), 33
FDA Drug Bulletin 43 [photo]
Federal Anti-Tampering Act [1983] TL, 51
Federal Food, Drug and Cosmetic Act [1938] TL, 19,
21, 30, 51
fees, user 63
Final Report of the Advisory Committee on the FDA [1991]
60 [photo]
Food and Drug Administration (FDA)
administrators FDA [photos]
Bureaus of:
Biological and Physical Sciences 28, 35
Biologics 47, 48
Drug Abuse Control TL (1968)
Foods, Pesticides and Product Safety 41
Science 41, 42
Scientific Research 35, 42
Scientific Standards and Evaluation 35, 39, 42
Veterinary Medicine 40
Citizens Advisory Committee recommendations 26,
27, 28
Divisions of :
Antibiotics 21, 28,
32
Antibiotics and Insulin Certification 35
Penicillin Control and Immunology 21
Pharmaceutical Sciences 42
Pharmacology 17, 21,
28
Drug Efficacy Study Implementation (DESI) 37
National Center for Antibiotics Analysis 48
reorganization [1969], as a result of Malek Report 42
Food and Drug Administration Modernization Act [1997] TL
Food, Drug and Insecticide Administration (FDIA) 14
food regulation
Bureau of Biological and Physical Sciences 28
Meat Inspection Act TL (1906)
Office of Food Control 11
Pharmacology Division of the FDA 17
Pure Food and Drugs Act TL (1906), 4
Fountain hearings [1964] 36
fraud
Drug and Biologics Fraud Branch 54
in drug labeling 9
mail fraud 10
Sherley Amendment 10
U.S. v. Johnson 7
G
Generic Drug Enforcement Act [1992] TL, 59
Generic Drugs Advisory Committee 59
H
Harrison Narcotic Act [1914] TL
I
informed consent 33
inpections of drug plants 30 [photo], 41 [photo]
inspectors, drug
conference of 1946 23 [photo]
undercover training 27 [photo]
inspectors, field 8 [photo]
Insulin Amendment [1941] TL, 21
investigational drugs TL (1987), 56
investigations
chloroform contamination 8
deaths related to anesthetics 13
dinitrophenol (for weight reduction) 16
of misconduct by FDA employees 59
Washington Post article, 1988 59
[photo]
K
Kefauver-Harris Amendments (Drug Amendments of 1962) TL, 32,
33, 34, 36, 37
L
laboratory, woman in 63 [photo]
legislation
Animal Drug Amendments [1968] TL
Comprehensive Drug Abuse Prevention & Control Act [1970] TL
Drug Abuse Control Amendments [1965] TL
Drug Importation Act [1848] TL
Drug Price Competition and Patent Term Restoration Act of 1984
TL, 53
Drug Regulation Reform bill [1978] 45
Durham-Humphrey Amendment of 1951 TL, 24
Factory Inspection Amendment [1953] TL
Federal Anti-Tampering Act [1983] TL (1982), 51
Federal Food, Drug and Cosmetic Act [1938] TL, 19,
21, 30, 51
Food & Drug Administration Modernization Act [1997] TL
Generic Drug Enforcement Act [1992] TL, 59
Harrison Narcotic Act [1914] TL
Insulin Amendment [1941] TL, 21
Kefauver-Harris Amendments (Drug Amendments of 1962) TL, 32,
33, 34, 36, 37
Meat Inspection Act [1906] TL
Orphan Drug Act of 1983 TL, 51
Penicillin Amendment [1945] TL, 21
Prescription Drug Marketing Act [1988] TL, 56
Prescription Drug User Fee Act [1992] TL, 61
Pure Food and Drugs Act [1906] intro,
TL, 1, 4, 7, 16, 18
Senate bill S.3815 30
Sherley Amendment [1912] TL, 7, 9
Uruguay Round Agreement Act [1994] TL
Vitamins & Minerals Amendments [1976] TL
Wheeler-Lea Act [1994] TL
M
Malek Report 41
Manufacturing practices 13, 30
accuracy 12
Controls Evaluation Branch (of New Drugs Branch) 34
preparation of ergot 15
Massengill Company 18
Meat Inspection Act [1906] TL
Medical Advisory Board 39
N
National Center for Drug Analysis (NCDA) 42
National Drug Experience Reporting System 43
new drug applications (NDAs) 24
approved NDAs, 1990-1998 61 [photo]
Citizens Advisory Committee recommendations 26
effects of Federal Food Drug and Cosmetic Act 19, 20
FDA offices responsible for 34, 40, 48, 54, 57
for thalidomide (Kevadon ) 31
for antibiotics 32, 35,
39
user fees 61
new molecular entities (NMEs) 61
nostrums (or "patent medicines") intro, gallery [photos]
Anglo-American Medicine Co.’s Heart Remedy gallery 16
Anti-Morbific, the Great Liver & Kidney Medicine gallery 18
Cassebeer’s Coca-Calisaya gallery 11
Dr. Bonker’s Celebrated Egyptian Oil gallery 2
Dr. Kilmer’s Swamp-Root gallery 10
Dr. Lindley’s Epilepsy Remedy gallery 4, gallery 24
Dr. Shreve’s Anti-Gall-Stone Remedy gallery 19
Dr. Towns’ Epilepsy Treatment gallery 7
Eckman’s Alternative gallery 8
Empress Eugenie Complexion Grain gallery 1
Excelsior Skin Food gallery 1
Fatoff Obesity Cream gallery 1
Harper’s Brain Food gallery 22
Harper’s Headache Remedy gallery 22
Hick’s Capudine Cure gallery 20
Kickapoo Sagwa Renovator gallery 15
Kintho Beauty Cream gallery 1
Kopp’s "Baby’s Friend" gallery 17
Lewis Gland Treatment gallery 6
Liquozone gallery 14
Mack Mahon the Rattlesnake Oil King’s Luminant for
Rheumatism and Catarrh gallery 3
Make-Man Tablets gallery 22
Mixer’s Cancer and Scrofula Syrup gallery 21
Neuropathic System of Treatment gallery 5
Rite-Wate gallery 12
Tott’s Teething Cordial gallery 17
Tuberculozine gallery 9
Warner’s Safe Diabetes Remedy gallery 23
White Eagle Indian Rattle-Snake Oil gallery 13
O
organizations and associations
American Medical Association intro,
TL (1905), 25
American Pharmaceutical Association intro, 2, 15
American Society of Hospital Pharmacists 25
General Federation of Women’s Clubs intro
National Academy of Sciences TL (1966), 37, 43
National Research Council TL (1966), 37
trade associations 12
U.S. Pharmacopeia (USP) TL (1820), 8,
12, 15
Orphan Drug Act of 1983 TL, 51
P
package inserts TL (1970), 45 [photo]
patent medicines (see "nostrums")
Penicillin Amendment [1945] TL, 21
Pharmacology
Division of, meeting 28 [photo]
divisions & offices of 4, 14, 17, 21, 28, 35
FDA laboratory 15 [photo]
Prescription Drug Marketing Act [1988] TL, 56
Prescription Drug User Fee Act [1992] TL, 61
prescription drugs, as differentiated from non-prescription drugs
24
protest by AIDS Coalition to Unleash Power 56
[photo]
publications
Adulteration of Various Substances Used in Medicine & the
Arts TL (1846)
Bureau By-Lines 29
Collier’s Weekly 3 [photo]
FDA Drug Bulletin 43 [photo]
Final Report of the Advisory Committee of the FDA 60 [photo]
Organizational Overview and Structure Report 47 [photo]
Understanding AIDS 58 [photo]
Pure Food and Drugs Act [1906] TL, 1,
4, 7, 16, 18
R
research
clinical trials 33, 34,
60
Drug Efficacy Study Implementation (DESI) 37
FDA offices responsible for 48
Malek Report 41
on manufacturing accuracy 12
on over-the-counter (OTC) drugs 38
study of adverse drug reaction reporting 25
study of drug standards 8
study of ergot pharmacology 15
S
samples
standardized product 12 [photo]
testing of 42 [photo]
Sherley Amendment [1912] TL, 7, 9
U
Understanding AIDS pamphlet [1988] 58
[photo]
Upjohn v. Finch TL (1970)
Uruguay Round Agreement Act [1994] TL
U.S. v. Cardiff TL (1952)
U.S. v. Johnson TL (1911), 7
U.S. v. Sullivan TL (1948)
V
veterinary medicine, divisions and offices of 14, 20, 22, 29, 39, 40
Vitamins & Minerals Amendments [1976] TL
W
Wheeler-Lea Act [1994] TL
William Merrell Company 31 |
